Recent Medical Device Recalls
The 500 most recent medical device recalls, newest first.
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3214-2026 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER…Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through… | Boston Scientific Corporation | 08/24/2026Open, Classified |
| Z-3243-2026 | SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3242-2026 | MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3241-2026 | MR 5300 Model Number (REF): 1. 782110, 2. 782152;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3240-2026 | Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3239-2026 | Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2.…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3238-2026 | Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3237-2026 | Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3236-2026 | Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3235-2026 | Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3234-2026 | Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3233-2026 | Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3232-2026 | Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers…A software issue will terminate an examination during the image reconstruction process if the scan… | Philips North America Llc | 08/21/2026Open, Classified |
| Z-3220-2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. | Midmark Corporation | 08/21/2026Open, Classified |
| Z-3219-2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. | Midmark Corporation | 08/21/2026Open, Classified |
| Z-3218-2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. | Midmark Corporation | 08/21/2026Open, Classified |
| Z-3217-2026 | Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic…A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used. | Midmark Corporation | 08/21/2026Open, Classified |
| Z-3256-2026 | REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesMyocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead… | DeRoyal Industries Inc | 08/20/2026Open, Classified |
| Z-3212-2026 | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes:…Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result… | ICU Medical, Inc. | 08/20/2026Open, Classified |
| Z-3177-2026 | Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT…Due to issue with endoscope adherence and inability to spray powder. Firm will provide an updated… | Wilson-Cook Medical Inc. | 08/20/2026Open, Classified |
| Z-3247-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3246-2026 | Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3245-2026 | Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3244-2026 | Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3226-2026 | SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm…The proximal thread depth of the spinal device is out of design specification. | Seaspine Orthopedics Corporation | 08/19/2026Open, Classified |
| Z-3216-2026 | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number:…Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a… | Olympus Corporation of the Americas | 08/19/2026Open, Classified |
| Z-3187-2026 | REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3186-2026 | REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3185-2026 | REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3184-2026 | REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMReusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3183-2026 | REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3182-2026 | REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &…Reusable access port system may crack or seperate during use. | Stryker Sustainability Solutions | 08/19/2026Open, Classified |
| Z-3165-2026 | NOxBOXi Nitric Oxide Delivery System.Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to… | Noxbox Ltd | 08/19/2026Open, Classified |
| Z-3080-2026 | BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump…Due to discrepancies in specific attributes in the performance data for infusion sets, which may lead to… | BD Switzerland Sarl | 08/19/2026Open, Classified |
| Z-3035-2026 Class II | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.…Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. | Olympus Corporation of the Americas | 08/18/2026Open, Classified |
| Z-3258-2026 | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2.…Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). | Intervascular, SAS | 08/12/2026Open, Classified |
| Z-3248-2026 | Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog…A small number of lenses within the affected lot are of the incorrect power. | CooperVision, Inc. | 08/12/2026Open, Classified |
| Z-3173-2026 | GM Helix Implant, REF: 109.984;There is a discrepancy between the product identification on the packaging and the dimensions of the implant… | Straumann USA LLC | 08/12/2026Open, Classified |
| Z-3150-2026 | Impella Optical Controller, Automated Impella Controller, Impella Connect Package with…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | Abiomed, Inc. | 08/12/2026Open, Classified |
| Z-3149-2026 | Impella Optical Controller with the below product descriptions and corresponding Product…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | Abiomed, Inc. | 08/12/2026Open, Classified |
| Z-3148-2026 | Automated Impella Controller (AIC) with the below product descriptions and corresponding…The potential for purge cassette recognition issues due to the failure of the purge flag component of the… | Abiomed, Inc. | 08/12/2026Open, Classified |
| Z-3250-2026 | ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The…Due to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. | Becton, Dickinson and Company | 08/11/2026Open, Classified |
| Z-3140-2026 | INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing…Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly… | CooperSurgical, Inc. | 08/11/2026Open, Classified |
| Z-3139-2026 | INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing…Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly… | CooperSurgical, Inc. | 08/11/2026Open, Classified |
| Z-3127-2026 | Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3126-2026 | Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3125-2026 | Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3124-2026 | Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3123-2026 | Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3122-2026 | Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE…The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3121-2026 | Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur… | Medline Industries, LP | 08/11/2026Open, Classified |
| Z-3066-2026 Class II | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches… | Baxter Healthcare Corporation | 08/11/2026Open, Classified |
| Z-3065-2026 Class II | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUSA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches… | Baxter Healthcare Corporation | 08/11/2026Open, Classified |
| Z-3255-2026 | Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV…The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator.… | Cardinal Health 200, LLC | 08/10/2026Open, Classified |
| Z-3254-2026 | Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU…The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator.… | Cardinal Health 200, LLC | 08/10/2026Open, Classified |
| Z-3230-2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK…Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the… | Medline Industries, LP | 08/10/2026Open, Classified |
| Z-3229-2026 | Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK…Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the… | Medline Industries, LP | 08/10/2026Open, Classified |
| Z-3154-2026 | Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… | AVID Medical, Inc. | 08/10/2026Open, Classified |
| Z-3153-2026 | Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… | AVID Medical, Inc. | 08/10/2026Open, Classified |
| Z-3152-2026 | Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… | AVID Medical, Inc. | 08/10/2026Open, Classified |
| Z-3151-2026 | Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject… | AVID Medical, Inc. | 08/10/2026Open, Classified |
| Z-3087-2026 Class II | 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | Fresenius Medical Care Renal Therapies… | 08/10/2026Open, Classified |
| Z-3086-2026 Class II | 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3CHeightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | Fresenius Medical Care Renal Therapies… | 08/10/2026Open, Classified |
| Z-3085-2026 Class II | 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | Fresenius Medical Care Renal Therapies… | 08/10/2026Open, Classified |
| Z-3084-2026 Class II | 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line… | Fresenius Medical Care Renal Therapies… | 08/10/2026Open, Classified |
| Z-2985-2026 | DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term…this is a downstream recall of class I recall RES 98777 | Bard Access Systems, Inc. | 08/10/2026Open, Classified |
| Z-2984-2026 | Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis…this is a downstream recall of class I recall RES 98777 | Bard Access Systems, Inc. | 08/10/2026Open, Classified |
| Z-3249-2026 | Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual… | Philips Ultrasound, LLC | 08/07/2026Open, Classified |
| Z-3224-2026 | PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model…The potential for the device to detach at the junction between the spring arm and suspension arm and fall… | Maquet SAS | 08/07/2026Open, Classified |
| Z-3176-2026 | Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501…Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness… | Happiest Baby, Inc | 08/07/2026Open, Classified |
| Z-3175-2026 | Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6…Extra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness… | Happiest Baby, Inc | 08/07/2026Open, Classified |
| Z-3113-2026 Class II | Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-3112-2026 Class II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-3111-2026 Class II | Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1.…An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters. | Atrium Medical Corporation | 08/07/2026Open, Classified |
| Z-3043-2026 Class II | Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3042-2026 Class II | Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3041-2026 Class II | Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3040-2026 Class II | Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP.…Philips has identified an unintended radiation issue with the Philips IQon, iCT, Ingenuity, and Brilliance… | Philips North America Llc | 08/07/2026Open, Classified |
| Z-3215-2026 | Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module…Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting… | Heidelberg Engineering GmbH | 08/06/2026Open, Classified |
| Z-3110-2026 Class II | Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that…Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud… | Lutronic Corporation | 08/06/2026Open, Classified |
| Z-3090-2026 Class I | Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule…Capsule may fail to attach to the esophagus or detach from the delivery device. Risks include patient… | Given Imaging Ltd. | 08/06/2026Open, Classified |
| Z-3083-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | Boston Scientific Corporation | 08/06/2026Open, Classified |
| Z-3082-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | Boston Scientific Corporation | 08/06/2026Open, Classified |
| Z-3081-2026 Class II | LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY…There is potential for a delay in AF Burden Alert notification affecting the server software which supports… | Boston Scientific Corporation | 08/06/2026Open, Classified |
| Z-3034-2026 Class II | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers…The linear actuator and rotational lock mechanism components may experience a mechanical failure that… | IMRIS Imaging Inc | 08/06/2026Open, Classified |
| Z-3033-2026 Class II | ORT200, operating room table, including the ORT200 Covered Table Assembly…The linear actuator and rotational lock mechanism components may experience a mechanical failure that… | IMRIS Imaging Inc | 08/06/2026Open, Classified |
| Z-3136-2026 Class II | Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Hemodialysis concentrates contain high endotoxin levels | Nipro Renal Soultions USA, Corporation | 08/05/2026Open, Classified |
| Z-3135-2026 Class II | Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Hemodialysis concentrates contain high endotoxin levels | Nipro Renal Soultions USA, Corporation | 08/05/2026Open, Classified |
| Z-3134-2026 Class II | MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Hemodialysis concentrates contain high endotoxin levels | Nipro Renal Soultions USA, Corporation | 08/05/2026Open, Classified |
| Z-3133-2026 Class II | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Hemodialysis concentrates contain high endotoxin levels | Nipro Renal Soultions USA, Corporation | 08/05/2026Open, Classified |
| Z-3174-2026 | Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number:…When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts… | PTW Freiburg | 08/04/2026Open, Classified |
| Z-3089-2026 Class II | Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number:…Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton… | B Braun Medical Inc | 08/04/2026Open, Classified |
| Z-3014-2026 Class II | Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital…Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray… | Canon Medical System, USA, INC. | 08/04/2026Open, Classified |
| Z-3257-2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A…Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer… | Baxter Healthcare Corporation | 08/03/2026Open, Classified |
| Z-3259-2026 | New York Embroidery Studio Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2…Gowns do not consistently meet the minimum liquid-barrier performance required. | New York Embroidery Studio, Inc. | 07/31/2026Open, Classified |
| Z-3210-2026 | Convenience kits CATARACT PACK DYNJ59881AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3209-2026 | Convenience kits MYRINGOTOMY PACK-LF DYNJ59097AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3208-2026 | Convenience kits MINOR PACK DYNJ58421A SPRINGHILL MINOR PACK DYNJ40734FKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3207-2026 | Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925AKits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not… | Medline Industries, LP | 07/31/2026Open, Classified |
| Z-3172-2026 | SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25The 6Fr suction catheter could not pass through the samples smoothly. | Well Lead Medical Co. Ltd | 07/31/2026Open, Classified |
| Z-3171-2026 | Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3170-2026 | Workflow Core Services V8, intended to provide set of services for storage and retrieval…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3169-2026 | Centricity PACS Server V7, intended for managing digital medical images and associated…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3168-2026 | Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3167-2026 | Enterprise Archive V8, software product for receiving, archiving, and sending electronic…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3166-2026 | Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving…Under certain conditions historical imaging data migrated from a legacy system may become incorrectly… | GE Healthcare | 07/31/2026Open, Classified |
| Z-3147-2026 | MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog…Some devices may not have been properly sterilized due to a manufacturing sterilization issue. | Bayer Medical Care, Inc. | 07/31/2026Open, Classified |
| Z-3146-2026 | Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA)…The packaging may not consistently maintain sterile barrier integrity. | Maquet Cardiopulmonary Gmbh | 07/31/2026Open, Classified |
| Z-3145-2026 | Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA)…The packaging may not consistently maintain sterile barrier integrity. | Maquet Cardiopulmonary Gmbh | 07/31/2026Open, Classified |
| Z-3144-2026 | Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA)…The packaging may not consistently maintain sterile barrier integrity. | Maquet Cardiopulmonary Gmbh | 07/31/2026Open, Classified |
| Z-3142-2026 | Philips PIC iX Essentials REF:867093Due to software malfunction, patient information system may freeze and become unresponsive. | Philips North America | 07/31/2026Open, Classified |
| Z-3141-2026 | Philips Patient Information Center iX REF:866389Due to software malfunction, patient information system may freeze and become unresponsive. | Philips North America | 07/31/2026Open, Classified |
| Z-3064-2026 Class II | HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN)…Surgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract… | Johnson & Johnson Surgical Vision, Inc. | 07/31/2026Open, Classified |
| Z-3206-2026 | SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3205-2026 | SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3204-2026 | TRIDENT 0 POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3203-2026 | SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3202-2026 | BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3201-2026 | ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3200-2026 | DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3199-2026 | ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3198-2026 | TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3197-2026 | ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3196-2026 | OMNIFIT SERIES I ACET. INSERT 10 22mm ID Catalog No. 2001-2246 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3195-2026 | AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant…Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged… | Howmedica Osteonics Corp. | 07/30/2026Open, Classified |
| Z-3192-2026 | Et Control, Software option for anesthesia gas machine to achieve and maintain targeted…Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… | Datex-Ohmeda, Inc. | 07/30/2026Open, Classified |
| Z-3191-2026 | Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… | Datex-Ohmeda, Inc. | 07/30/2026Open, Classified |
| Z-3190-2026 | Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… | Datex-Ohmeda, Inc. | 07/30/2026Open, Classified |
| Z-3189-2026 | Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000Anesthesia Delivery Systems containing certain electronic gas mixer assemblies can automatically transition… | Datex-Ohmeda, Inc. | 07/30/2026Open, Classified |
| Z-3143-2026 | Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13…Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to… | GE Medical Systems Information Technologies… | 07/30/2026Open, Classified |
| Z-2872-2026 Class I | BD Needle Kit for Powered Driver 15mm x 15Ga, REF: D015151NK, BD Needle Kit for Powered…After placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to… | Bard Access Systems, Inc. | 07/30/2026Open, Classified |
| Z-3225-2026 | CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer…Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps… | Fresenius Medical Care Renal Therapies… | 07/29/2026Open, Classified |
| Z-3138-2026 Class II | AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BThe convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags… | Windstone Medical Packaging, Inc. | 07/29/2026Open, Classified |
| Z-3132-2026 | StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | Nova Biomedical Corporation | 07/29/2026Open, Classified |
| Z-3131-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63910. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | Nova Biomedical Corporation | 07/29/2026Open, Classified |
| Z-3130-2026 | StatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | Nova Biomedical Corporation | 07/29/2026Open, Classified |
| Z-3129-2026 | StatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | Nova Biomedical Corporation | 07/29/2026Open, Classified |
| Z-3128-2026 | StatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.A software synchronization/timing issue in the barcode scanning and patient data processing component that… | Nova Biomedical Corporation | 07/29/2026Open, Classified |
| Z-3105-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3104-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3103-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3102-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3101-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3100-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3099-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3098-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3097-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3096-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3095-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3094-2026 Class II | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:…The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a… | Cardinal Health 200, LLC | 07/29/2026Open, Classified |
| Z-3047-2026 Class II | STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074…A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified | Diagnostica Stago, Inc. | 07/29/2026Open, Classified |
| Z-3032-2026 Class II | healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein…Test manufactured with an expired ingredient which may present as either a false negative or positive. | Healthmark Industries Co., Inc. | 07/29/2026Open, Classified |
| Z-3031-2026 Class II | healthmark ProChek-II, Model Number PT-313, PT-201-12Test manufactured with an expired ingredient which may present as either a false negative or positive. | Healthmark Industries Co., Inc. | 07/29/2026Open, Classified |
| Z-3223-2026 | REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post ValveLabeling; Oxygen Cylinders do not contain required medical gas labeling | Ventec Life Systems, Inc. | 07/28/2026Open, Classified |
| Z-3222-2026 | REF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated ConserverLabeling; Oxygen Cylinders do not contain required medical gas labeling | Ventec Life Systems, Inc. | 07/28/2026Open, Classified |
| Z-3221-2026 | HF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post ValveLabeling; Oxygen Cylinders do not contain required medical gas labeling | Ventec Life Systems, Inc. | 07/28/2026Open, Classified |
| Z-3178-2026 | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result… | restor3d Inc. | 07/27/2026Open, Classified |
| Z-3120-2026 Class II | HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067…Due to a damaged (over stretched) membrane tail that causes an intermittent fault. | HeartSine Technologies Ltd | 07/27/2026Open, Classified |
| Z-3231-2026 | VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference…The issue is related to card pouch damage associated with a portion of the lot which was produced on a… | Biomerieux Inc | 07/24/2026Open, Classified |
| Z-2940-2026 Class II | Ami HTXMomentary absence of On-Screen "X-Ray On" banner during run readiness check. | Spectral Instruments Inc | 07/24/2026Open, Classified |
| Z-2939-2026 Class II | Lago XMomentary absence of On-Screen "X-Ray On" banner during run readiness check. | Spectral Instruments Inc | 07/24/2026Open, Classified |
| Z-3181-2026 | Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs…Blood culture convenience kits contain a component subject to a drug recall that due to an an open or… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-3137-2026 | Medline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NThe kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile… | Medline Industries, LP | 07/23/2026Open, Classified |
| Z-3107-2026 Class I | Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF:…Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-3106-2026 Class I | Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP…Kits containing Sodium Chloride ampules subject to another recall are recalled due to potentially… | Medical Action Industries, Inc. 306 | 07/23/2026Open, Classified |
| Z-3088-2026 Class II | Velys Enabling Tech Robotic-Assist Station REF: 451611001Software issue within robotic controller which may cause unintended movement of the robotic arm during bone… | Medos International Sarl | 07/23/2026Open, Classified |
| Z-3261-2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete… | AVID Medical, Inc. | 07/22/2026Open, Classified |
| Z-3260-2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete… | AVID Medical, Inc. | 07/22/2026Open, Classified |
| Z-3194-2026 | Halyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1…Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with… | AVID Medical, Inc. | 07/22/2026Open, Classified |
| Z-3188-2026 | Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1)…A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the… | Boston Scientific Corporation | 07/22/2026Open, Classified |
| Z-3030-2026 Class II | FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemSoftware issue may cause the ruler measurement to be inaccurate. | FUJIFILM Healthcare Americas Corporation | 07/22/2026Open, Classified |
| Z-3004-2026 Class II | Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationSoftware issue may cause measurements to be displayed inaccurately. | Merge Healthcare, Inc. | 07/22/2026Open, Classified |
| Z-3193-2026 | Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its… | Mirion Technologies (Capintec), Inc. | 07/20/2026Open, Classified |
| Z-3079-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3078-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3077-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3076-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3075-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3074-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3073-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3072-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3071-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3070-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3069-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3068-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3067-2026 Class II | Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP…Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected… | Medline Industries, LP | 07/20/2026Open, Classified |
| Z-3039-2026 Class II | FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | GE Medical Systems Information Technologies… | 07/20/2026Open, Classified |
| Z-3038-2026 Class II | PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | GE Medical Systems Information Technologies… | 07/20/2026Open, Classified |
| Z-3037-2026 Class II | PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | GE Medical Systems Information Technologies… | 07/20/2026Open, Classified |
| Z-3036-2026 Class II | PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all… | GE Medical Systems Information Technologies… | 07/20/2026Open, Classified |
| Z-3013-2026 Class II | Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version:…A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate… | Midmark Corporation | 07/20/2026Open, Classified |
| Z-3012-2026 Class II | Midmark IQecg Digital ECG, Model/Catalog Number: 4-000-0061, 4-000-0062 Software…A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate… | Midmark Corporation | 07/20/2026Open, Classified |
| Z-2967-2026 Class II | Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF#…Due to a firmware defect, the portable organ transfer device datalogger may lose its configuration… | Paragonix Technologies Inc. | 07/20/2026Open, Classified |
| Z-2954-2026 Class II | Dentsply Sirona Capsule Mixer Model No. 5546068Potential for electrical discharge from unit when unplugged. | SDI Limited | 07/20/2026Open, Classified |
| Z-2927-2026 Class II | Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30166901…Certain lots of Neisseria meningitidis Gp C 2ml/VL, R30166901, are not performing to IFU criteria not… | Remel Europe Ltd. | 07/17/2026Open, Classified |
| Z-2935-2026 Class II | Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim…Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim may inadvertently contain… | Straumann USA LLC | 07/16/2026Open, Classified |
| Z-2932-2026 Class II | Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235…Two software related issues affecting Philips Azurion R3.0 and R3.1 systems: 1) Potential image quality… | Philips Medical Systems Nederland B.V. | 07/16/2026Open, Classified |
| Z-2931-2026 Class II | Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079…Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that… | Philips Medical Systems Nederland B.V. | 07/16/2026Open, Classified |
| Z-2877-2026 Class II | FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The…Firm has identified mismatches between the outbreak strain and the reference strain used in the development… | Biofire Defense | 07/16/2026Open, Classified |
| Z-3211-2026 | Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907…Bone fixation staple requires a new 510(k); the performance characteristics of this device have not been… | F & A Foundation | 07/15/2026Open, Classified |
| Z-2979-2026 Class I | BMC/REACTHEALTH Luna G3 APAP REF LG 3600Retroactive reporting for 2024 rework conducted at the 3B/React Health warehouse | BMC Medical Co., Ltd. | 07/15/2026Open, Classified |
| Z-2974-2026 Class II | Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or…a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test… | Beckman Coulter Inc. | 07/15/2026Open, Classified |
| Z-2973-2026 Class II | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower:…a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test… | Beckman Coulter Inc. | 07/15/2026Open, Classified |
| Z-3109-2026 Class II | Halyard IV Start Kit Non-Sterile REF: KRIV26-02Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which lacks sterility… | AVID Medical, Inc. | 07/14/2026Open, Classified |
| Z-3108-2026 | Halyard IV START KIT NON-STERILE REF: KRIV26-02Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are… | AVID Medical, Inc. | 07/14/2026Open, Classified |
| Z-3093-2026 Class II | Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers:…Complaints of blue-green discoloration in product | Fresenius Medical Care Renal Therapies… | 07/14/2026Open, Classified |
| Z-3092-2026 Class II | NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers:…Complaints of blue-green discoloration in product | Fresenius Medical Care Renal Therapies… | 07/14/2026Open, Classified |
| Z-3091-2026 Class II | GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid…Complaints of blue-green discoloration in product | Fresenius Medical Care Renal Therapies… | 07/14/2026Open, Classified |
| Z-3018-2026 Class II | CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B…Suture anchor may contain incorrect patient implant card which may result in incorrect device identification… | ConMed Corporation | 07/14/2026Open, Classified |
| Z-2998-2026 Class II | Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli…Hollister has identified that select lots of the catheters identified in the above table may exhibit a… | Hollister Ulc | 07/14/2026Open, Classified |
| Z-2962-2026 Class II | Suture Cinch Long 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Boston Scientific Corporation | 07/14/2026Open, Classified |
| Z-2961-2026 Class II | OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Device may fail to deploy the cinch implant and/or fail to cut the suture as intended. | Boston Scientific Corporation | 07/14/2026Open, Classified |
| Z-2949-2026 Class II | Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2948-2026 Class II | Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Number: PN33NBMYD; 2)…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2947-2026 Class II | Cardinal Health Presource Kits: 1) CHI STD NEURO CRANI OPT 2 , Catalog Number:…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2946-2026 Class II | Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF; 2)…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2945-2026 Class II | Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2944-2026 Class II | Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMBCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2943-2026 Class II | Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number:…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2942-2026 Class II | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY…Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed… | Cardinal Health 200, LLC | 07/14/2026Open, Classified |
| Z-2993-2026 Class II | Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire… | Medline Industries, LP | 07/13/2026Open, Classified |
| Z-2992-2026 Class II | Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire… | Medline Industries, LP | 07/13/2026Open, Classified |
| Z-2991-2026 Class II | Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU…Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire… | Medline Industries, LP | 07/13/2026Open, Classified |
| Z-2982-2026 Class II | MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLWLoaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-2981-2026 Class II | MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-2980-2026 Class II | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump… | Medtronic MiniMed, Inc. | 07/13/2026Open, Classified |
| Z-2976-2026 Class II | Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13…Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which… | Siemens Healthcare Diagnostics, Inc. | 07/13/2026Open, Classified |
| Z-2975-2026 Class II | Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mLDue to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which… | Siemens Healthcare Diagnostics, Inc. | 07/13/2026Open, Classified |
| Z-2970-2026 Class II | Blanketrol III, Model 233; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-2969-2026 Class II | Innercool Coolblue Console, Model STx; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-2968-2026 Class II | Blanketrol II Model 222S; Thermal regulating system.Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and… | Gentherm Medical, LLC | 07/13/2026Open, Classified |
| Z-2966-2026 Class II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085…Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being… | Siemens Healthcare Diagnostics Products Ltd. | 07/13/2026Open, Classified |
| Z-2965-2026 Class II | Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981…Syphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being… | Siemens Healthcare Diagnostics Products Ltd. | 07/13/2026Open, Classified |
| Z-2957-2026 Class II | Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2…Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece… | Kico Knee Innovation Company | 07/13/2026Open, Classified |
| Z-2933-2026 Class II | OBP Medical , ER-Spec Single-Use Vaginal Speculum with LED Light Source, X-Small REF:…There is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may… | OBP Medical Corporation | 07/13/2026Open, Classified |
| Z-2929-2026 Class II | GM Helix Implant, Endosseous Dental Implant Article No. 109.984There may be a mismatch between the implant contained inside the packaging and the information described on… | Straumann USA LLC | 07/13/2026Open, Classified |
| Z-3029-2026 Class II | Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3028-2026 Class II | Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3027-2026 Class II | Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3026-2026 Class II | Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3025-2026 Class II | Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3024-2026 Class II | Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3023-2026 Class II | Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375MKits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3022-2026 Class II | Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3021-2026 Class II | Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991SKits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3020-2026 Class II | Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-3019-2026 Class II | Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2)…Kits contain a potentially contaminated component which were recalled by the manufacturer | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2999-2026 Class II | Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330Component labeling discrepancy | Medline Industries, LP | 07/10/2026Open, Classified |
| Z-2972-2026 Class III | Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… | Paragon 28, Inc. | 07/10/2026Open, Classified |
| Z-2971-2026 Class III | Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number…Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels… | Paragon 28, Inc. | 07/10/2026Open, Classified |
| Z-2964-2026 Class II | Halyard LAVH PACK, Model/Catalog Number: USAR053-11A customer complaint reported that the Clearify Visualization System (5303907) leaked in a kit. As a result… | AVID Medical, Inc. | 07/10/2026Open, Classified |
| Z-2878-2026 Class II | GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592Portrait Core Services Software version V1.2.0 Security Vulnerability | GE Medical Systems Information Technologies… | 07/10/2026Open, Classified |
| Z-3016-2026 Class II | Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1)…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the… | Henry Schein Inc. | 07/09/2026Open, Classified |
| Z-3015-2026 Class II | Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr…Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the… | Henry Schein Inc. | 07/09/2026Open, Classified |
| Z-3011-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3010-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3009-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3008-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3007-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3006-2026 Class II | Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-3005-2026 Class II | Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR…Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural… | AVID Medical, Inc. | 07/09/2026Open, Classified |
| Z-2978-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | Boston Scientific Corporation | 07/09/2026Open, Classified |
| Z-2977-2026 Class I | Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number…Potential for arterial sheath tip separation or partial tip separation during use. | Boston Scientific Corporation | 07/09/2026Open, Classified |
| Z-2997-2026 Class II | Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… | Medline Industries, LP | 07/08/2026Open, Classified |
| Z-2996-2026 Class II | Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… | Medline Industries, LP | 07/08/2026Open, Classified |
| Z-2995-2026 Class II | Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… | Medline Industries, LP | 07/08/2026Open, Classified |
| Z-2994-2026 Class II | Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU…Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and… | Medline Industries, LP | 07/08/2026Open, Classified |
| Z-2983-2026 Class II | Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an… | Fort Defiance Industries, LLC | 07/08/2026Open, Classified |
| Z-2960-2026 Class II | TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within… | Tobii Dynavox Llc | 07/08/2026Open, Classified |
| Z-2959-2026 Class II | TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within… | Tobii Dynavox Llc | 07/08/2026Open, Classified |
| Z-2837-2026 Class II | Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected…Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Integrated Medcraft LLC | 07/07/2026Open, Classified |
| Z-2836-2026 Class II | FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002.…Devices could potentially contain an occluded or partially occluded Guedel Airway tip. | Integrated Medcraft LLC | 07/07/2026Open, Classified |
| Z-2761-2026 Class II | Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual…Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image… | Olympus Corporation of the Americas | 07/07/2026Open, Classified |
| Z-3213-2026 | Pi-Cardia Inc. ShortCut REF: Z-A-20.003-USTransfemoral catheter, positing arm may detached due to weld issue. | Pi Cardia Ltd | 07/06/2026Open, Classified |
| Z-2986-2026 Class II | Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703, 423704, 423705…Urostomy Pouches may leak from cap during use. | ConvaTec, Inc | 07/06/2026Open, Classified |
| Z-2934-2026 Class II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating…The affected Endo-Model replacement set for a Rotating Hinge tibial plateau incorrectly contains a Pure… | Waldemar Link GmbH & Co. KG (Mfg Site) | 07/06/2026Open, Classified |
| Z-2890-2026 Class II | Atellica CH Urine Albumin REF: 11537225processing Atellica CH Urine Albumin (UAlb) tests on Atellica CH and Atellica CI analyzers may lead to the… | Siemens Healthcare Diagnostics, Inc. | 07/06/2026Open, Classified |
| Z-2873-2026 Class I | Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection…Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the… | Spectra Medical Devices, Llc | 07/06/2026Open, Classified |
| Z-2820-2026 Class II | OsteoBallast, 45 x 17.5 mm (SeaSpine Brand), REF: 56800095. Ballast, 45 x 17.5 mm…Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender… | IsoTis OrthoBiologics, Inc. | 07/02/2026Open, Classified |
| Z-2956-2026 Class II | Cardiac Workstation 7000. Product Number: 860441.Device will intermittently provide inaccurate data related to native heart rate. | Philips North America Llc | 07/01/2026Open, Classified |
| Z-2955-2026 Class II | Cardiac Workstation 5000. Product Number: 860439.Device will intermittently provide inaccurate data related to native heart rate. | Philips North America Llc | 07/01/2026Open, Classified |
| Z-2896-2026 Class II | 5-PLASMA Bivalirudin Control, Model Number 5D-44905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | Aniara Diagnostica LLC | 07/01/2026Open, Classified |
| Z-2895-2026 Class II | 5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | Aniara Diagnostica LLC | 07/01/2026Open, Classified |
| Z-2894-2026 Class II | 5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been… | Aniara Diagnostica LLC | 07/01/2026Open, Classified |
| Z-2871-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475640 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | Biomet, Inc. | 07/01/2026Open, Classified |
| Z-2870-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475635 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | Biomet, Inc. | 07/01/2026Open, Classified |
| Z-2869-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475630 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | Biomet, Inc. | 07/01/2026Open, Classified |
| Z-2868-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475625 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | Biomet, Inc. | 07/01/2026Open, Classified |
| Z-2867-2026 Class II | Intramedullary Bone Saw Blade Assembly Model/Catalog Number: 475620 Product Description:…Zimmer Biomet is conducting a medical device recall removal for various sizes of the Intramedullary Bone Saw… | Biomet, Inc. | 07/01/2026Open, Classified |
| Z-2833-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2832-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2831-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2830-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2829-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2828-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-2827-2026 Class II | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030.Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Stryker GmbH | 07/01/2026Open, Classified |
| Z-3017-2026 Class II | Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126…Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no… | Fresenius Medical Care Renal Therapies… | 06/30/2026Open, Classified |
| Z-2987-2026 Class II | Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard…Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the… | restor3d Inc. | 06/30/2026Open, Classified |
| Z-2963-2026 Class II | GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; ventilator, continuous…Maquet Critical Care AB, a subsidiary of Getinge, is voluntarily recalling Y sensor module, part of the… | Maquet Critical Care AB | 06/30/2026Open, Classified |
| Z-2926-2026 Class II | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product…Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels… | Medline Industries, LP | 06/30/2026Open, Classified |
| Z-2925-2026 Class II | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count, Product Number…Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels… | Medline Industries, LP | 06/30/2026Open, Classified |
| Z-2924-2026 Class II | Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product Number…Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels… | Medline Industries, LP | 06/30/2026Open, Classified |
| Z-2923-2026 Class II | Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count, Product…Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels… | Medline Industries, LP | 06/30/2026Open, Classified |
| Z-2875-2026 Class II | Merge OrthoPACS, medical imaging diagnostic workstationMerge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient… | Merge Healthcare, Inc. | 06/30/2026Open, Classified |
| Z-2874-2026 Class II | Merge PACS, medical imaging diagnostic workstationMerge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient… | Merge Healthcare, Inc. | 06/30/2026Open, Classified |
| Z-2840-2026 Class II | Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-2839-2026 Class II | Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1.…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-2838-2026 Class II | Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:…Potential for breach in sterile barrier of device packaging. | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-2775-2026 Class II | SnapshotGLO Wound Imaging Device, Model KB100, KB100AA.The software controlling the wound imaging device's battery charging circuit was not designed to recognize… | Kent Imaging, Inc. | 06/30/2026Open, Classified |
| Z-2766-2026 Class I | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in… | Baxter Healthcare Corporation | 06/30/2026Open, Classified |
| Z-2725-2026 Class II | Rapid Refill Continuous Injection System, UPN M00566001Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk… | Boston Scientific Corporation | 06/30/2026Open, Classified |
| Z-3003-2026 Class II | American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90HThe Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | American Contract Systems Inc | 06/29/2026Open, Classified |
| Z-3002-2026 Class II | American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | American Contract Systems Inc | 06/29/2026Open, Classified |
| Z-3001-2026 Class II | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10ANThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | American Contract Systems Inc | 06/29/2026Open, Classified |
| Z-3000-2026 Class II | American Contract System Convenience Kit, CV B PACK, Model/Catalog Number: TNCB10AMThe Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber… | American Contract Systems Inc | 06/29/2026Open, Classified |
| Z-2928-2026 Class II | Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039…Firmware issue potentially leading to loss of geometry movements. | Philips Medical Systems Nederland B.V. | 06/29/2026Open, Classified |
| Z-2911-2026 Class II | Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated…Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated… | Contego Medical, Inc | 06/29/2026Open, Classified |
| Z-2876-2026 Class II | GE Healthcare MAC VU360, REF# part number 2030361-023; ElectrocardiographSoftware issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview… | GE Medical Systems Information Technologies… | 06/29/2026Open, Classified |
| Z-2988-2026 Class II | Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Potential of failing to trigger clinical scan during Bolus Tracking. | Philips Healthcare (Suzhou) Co., Ltd. | 06/26/2026Open, Classified |
| Z-2938-2026 Class II | ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000A strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit… | Erbe USA Inc | 06/26/2026Open, Classified |
| Z-2917-2026 Class II | Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP…Black depth markings may detach from the outer sheath of the coaxial dilator introducer component of… | Galt Medical Corporation | 06/26/2026Open, Classified |
| Z-2889-2026 Class II | REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following…Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading… | Beckman Coulter Inc. | 06/26/2026Open, Classified |
| Z-2888-2026 Class II | REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the…Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading… | Beckman Coulter Inc. | 06/26/2026Open, Classified |
| Z-2881-2026 Class III | Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog…out-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant… | Siemens Healthcare Diagnostics, Inc. | 06/26/2026Open, Classified |
| Z-2880-2026 Class III | Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319ULOut-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot… | Siemens Healthcare Diagnostics, Inc. | 06/26/2026Open, Classified |
| Z-3119-2026 Class II | Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-3118-2026 Class II | Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-3117-2026 Class II | Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF:…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-3116-2026 Class II | Products that contain the Pericare Wipes: *Bardex I.C. Complete Care Foley Catheter Tray…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-3115-2026 Class II | Products that contain the Pericare Wipes: Bard Foley Tray With Lubri-Sil All-Silicone…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-3114-2026 Class II | Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF:…Due to complaints received indicating presence of contamination on the surface of pericare wipes provided… | C.R. Bard Inc | 06/25/2026Open, Classified |
| Z-2853-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2852-2026 Class II | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front Software…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2851-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2850-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 4 Model/Catalog Number: Q6 Edge 4…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2849-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2848-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2847-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2846-2026 Class II | Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2845-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2844-2026 Class II | Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2843-2026 Class II | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Number: Q6 Edge…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2842-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2841-2026 Class II | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum…If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while… | Pride Mobility Products Corp. | 06/25/2026Open, Classified |
| Z-2735-2026 Class I | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger… | ResMed Ltd. | 06/25/2026Open, Classified |
| Z-2936-2026 Class II | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based…Due to increase in false negative results | BioFire Diagnostics, LLC | 06/24/2026Open, Classified |
| Z-2922-2026 Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2921-2026 Class II | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2920-2026 Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2919-2026 Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2918-2026 Class II | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | Covidien, LP | 06/24/2026Open, Classified |
| Z-2860-2026 Class II | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i…Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to… | Maquet Critical Care AB | 06/24/2026Open, Classified |
| Z-2811-2026 Class II | EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2810-2026 Class II | EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2809-2026 Class II | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2808-2026 Class II | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2807-2026 Class II | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2806-2026 Class II | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with…Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and… | Medtronic Perfusion Systems | 06/24/2026Open, Classified |
| Z-2759-2026 Class II | Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous…ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid… | ICU Medical Inc. | 06/24/2026Open, Classified |
| Z-2958-2026 Class II | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530…Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following… | Arrowhead DE LLC | 06/23/2026Open, Classified |
| Z-2835-2026 Class II | Charger for the Therabody Theragun, G4 PRO massage device, and products which include…Charging cradle for the device may overheat while charging the device's removable battery pack, presenting… | Therabody, Inc | 06/23/2026Open, Classified |
| Z-2856-2026 Class II | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control…A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When this occurs… | Munevo GmbH | 06/19/2026Open, Classified |
| Z-2771-2026 Class II | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001…Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the… | Boston Scientific Corporation | 06/19/2026Open, Classified |
| Z-2760-2026 Class II | Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended…Product may experience accelerated roller wear and potential deformation due to interference between the… | Ferno-Washington Inc | 06/19/2026Open, Classified |
| Z-2910-2026 Class II | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LFIncorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal… | Freudenberg Medical, LLC | 06/17/2026Open, Classified |
| Z-2909-2026 Class II | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEFIncorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal… | Freudenberg Medical, LLC | 06/17/2026Open, Classified |
| Z-2893-2026 Class II | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2892-2026 Class II | Philips Azurion under the following System Descriptions and corresponding model numbers:…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2891-2026 Class II | Philips Allura under the following System Descriptions and corresponding model numbers:…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | Philips Medical Systems Nederland B.V. | 06/17/2026Open, Classified |
| Z-2879-2026 Class I | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD…Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in… | Boston Scientific Neuromodulation Corporation | 06/17/2026Open, Classified |
| Z-2819-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2818-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2817-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2816-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2815-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2814-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray -…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2813-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2812-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part…Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions… | Windstone Medical Packaging, Inc. | 06/17/2026Open, Classified |
| Z-2768-2026 Class II | Ventriculostomy Kit, REF: 46154Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system… | Medtronic Neurosurgery | 06/17/2026Open, Classified |
| Z-2758-2026 Class II | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod…Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch… | Paragon 28, Inc. | 06/17/2026Open, Classified |
| Z-2941-2026 Class II | 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext…Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product… | BD Switzerland Sarl | 06/16/2026Open, Classified |
| Z-2854-2026 Class II | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Software Version:…Due to a software issue within the WebApp that potentially prevents the user to overwrite the results. | Copan WASP | 06/16/2026Open, Classified |
| Z-2778-2026 Class II | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or… | Medtronic MiniMed, Inc. | 06/16/2026Open, Classified |
| Z-2776-2026 Class II | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery… | Olympus Corporation of the Americas | 06/16/2026Open, Classified |
| Z-2644-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | Accuray Incorporated | 06/16/2026Open, Classified |
| Z-2640-2026 Class II | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator…In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion… | Accuray Incorporated | 06/16/2026Open, Classified |
| Z-2953-2026 Class II | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.Devices could potentially be occluded or partially occluded. | Intersurgical Inc | 06/15/2026Open, Classified |
| Z-2952-2026 Class II | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.Devices could potentially be occluded or partially occluded. | Intersurgical Inc | 06/15/2026Open, Classified |
| Z-2930-2026 Class II | GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060. The…Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. | Terumo Medical Corporation | 06/15/2026Open, Classified |
| Z-2908-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2907-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2906-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2905-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2904-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2903-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2902-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2901-2026 Class II | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2804-2026 Class II | L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620Catheters, indicated for short/long-term peripheral access to central venous system for the administration… | Argon Medical Devices, Inc | 06/15/2026Open, Classified |
| Z-2803-2026 Class II | L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF:…Catheters, indicated for short/long-term peripheral access to central venous system for the administration… | Argon Medical Devices, Inc | 06/15/2026Open, Classified |
| Z-3063-2026 Class II | Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3062-2026 Class II | Medline Convenience Kits: 1) ORTHO ASPIRATION KIT, Model Number: DYKM1636A; 2) SHOULD…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3061-2026 Class II | Medline Convenience Kits: 1) EYE KIT, Model Number: DYKM2751; 2) EYE KIT, Model Number:…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3060-2026 Class II | Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702BThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3059-2026 Class II | Medline Convenience Kits: 1) LABOR CDS, Model Number: CDS981762B; 2) VAG DELIVERY…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3058-2026 Class II | Medline Convenience Kits: 1) PRE-OP KIT, Catalog Number: DYKS1043F; 2) PRE OP KIT…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3057-2026 Class II | Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3056-2026 Class II | Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3055-2026 Class II | Medline Convenience Kits: 1) ARTERIAL LINE INSERTION KIT, Model Number: ART1295The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3054-2026 Class II | Medline Convenience Kits: 1) IV START KIT, Catalog Number: DYNDV2520; 2) PERIPHERAL LAB…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3053-2026 Class II | Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3052-2026 Class II | Medline Convenience Kits: 1) COLORECTAL ME, Model Number: DYNJ906437DThe kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3051-2026 Class II | Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3050-2026 Class II | Medline Convenience Kits: 1) DYKM1414, Catalog Number: DYKM1414; 2) DYKM1414, Catalog…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3049-2026 Class II | Medline Convenience Kits: 1) CDS840396X, Catalog Number: CDS840396X; 2) CDS840396Y…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-3048-2026 Class II | Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2)…The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach… | Medline Industries, LP | 06/12/2026Open, Classified |
| Z-2746-2026 Class II | ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement…The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the… | Tosoh Bioscience Inc | 06/12/2026Open, Classified |
| Z-2857-2026 Class II | Brand Name: OXOS Medical, Inc Product Name: MC2 Portable X-Ray System Model/Catalog…Due to a defective circuit board that overheats | Oxos Medical Inc | 06/11/2026Open, Classified |
| Z-2791-2026 Class II | Medline medical convenience kits labeled as: 1) TOTAL JOINT PACK Medline Kit SKU…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | Medline Industries, LP | 06/11/2026Open, Classified |
| Z-2790-2026 Class II | Medline medical convenience kits labeled as: NEURO PACK, Medline Kit SKU DYNJ59397PMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | Medline Industries, LP | 06/11/2026Open, Classified |
| Z-2789-2026 Class II | Medline medical convenience kits labeled as: 1) SHOULDER PACK, Medline Kit SKU…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | Medline Industries, LP | 06/11/2026Open, Classified |
| Z-2788-2026 Class II | Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN HEART MOSES, Medline…Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL… | Medline Industries, LP | 06/11/2026Open, Classified |
| Z-2757-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2756-2026 Class II | FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2755-2026 Class II | FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2754-2026 Class II | FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and…Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2753-2026 Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2752-2026 Class II | FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterLabeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2751-2026 Class II | FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2750-2026 Class II | FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401…Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA… | Boston Scientific Corporation | 06/11/2026Open, Classified |
| Z-2693-2026 Class I | ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2692-2026 Class I | ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2691-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2690-2026 Class I | ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2689-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2688-2026 Class I | ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2687-2026 Class I | ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2686-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2685-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2684-2026 Class I | ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2683-2026 Class I | ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2682-2026 Class I | ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2681-2026 Class I | ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit…A potential for introducer sheath leakage from under the sheath cap and along the hub score lines… | Abiomed, Inc. | 06/11/2026Open, Classified |
| Z-2652-2026 Class II | Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium…The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2651-2026 Class II | IQon Spectral CT IQon Spectral CT UpgradesThe clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2650-2026 Class II | Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000…The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be… | Philips Medical Systems | 06/11/2026Open, Classified |
| Z-2951-2026 Class II | Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to…Software issue that can cause an increase in spontaneous software closures. | Foundation Medicine, Inc. | 06/10/2026Open, Classified |
| Z-2737-2026 Class II | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF…Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which… | Medline Industries, LP | 06/10/2026Open, Classified |
| Z-2736-2026 Class II | Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which… | Medline Industries, LP | 06/10/2026Open, Classified |
| Z-2732-2026 Class II | Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2731-2026 Class II | Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2730-2026 Class II | Orthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2729-2026 Class II | Orthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral…Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail… | Orthofix U.S. LLC | 06/10/2026Open, Classified |
| Z-2724-2026 Class II | ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpIn a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the… | ICU Medical, Inc. | 06/10/2026Open, Classified |
| Z-2723-2026 Class II | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number…In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the… | ICU Medical, Inc. | 06/10/2026Open, Classified |
| Z-2680-2026 Class I | Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2679-2026 Class I | Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2678-2026 Class I | Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer…Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the… | Oscor Inc. | 06/10/2026Open, Classified |
| Z-2717-2026 Class II | Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US…Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk. | CMR Surgical Limited | 06/09/2026Open, Classified |
| Z-2674-2026 Class II | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems…Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized… | Zimmer Surgical Inc | 06/09/2026Open, Classified |
| Z-2673-2026 Class II | Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual…Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized… | Zimmer Surgical Inc | 06/09/2026Open, Classified |
| Z-2887-2026 Class II | HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30)…Due to incorrect cartridges include in affected products that there is the potential for false-susceptible… | Hardy Diagnostics | 06/08/2026Open, Classified |
| Z-2866-2026 Class II | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2865-2026 Class II | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2864-2026 Class II | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2863-2026 Class II | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2862-2026 Class II | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600There has been an increased amount in reported complaints consistently describing leaking from the handpiece… | Stryker Corporation | 06/08/2026Open, Classified |
| Z-2802-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | Windstone Medical Packaging, Inc. | 06/08/2026Open, Classified |
| Z-2801-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | Windstone Medical Packaging, Inc. | 06/08/2026Open, Classified |
| Z-2800-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | Windstone Medical Packaging, Inc. | 06/08/2026Open, Classified |
| Z-2799-2026 Class II | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part…The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific… | Windstone Medical Packaging, Inc. | 06/08/2026Open, Classified |
| Z-2787-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2786-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2785-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2784-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2783-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2782-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2781-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2780-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2779-2026 Class II | Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18…Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2774-2026 Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF…Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and… | Micro Therapeutics, Inc. | 06/08/2026Open, Classified |
| Z-2773-2026 Class II | Pipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF…Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and… | Micro Therapeutics, Inc. | 06/08/2026Open, Classified |
| Z-2765-2026 Class I | MEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU…The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2764-2026 Class I | MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU…The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in… | Medline Industries, LP | 06/08/2026Open, Classified |
| Z-2703-2026 Class II | Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI… | Siemens Healthcare Diagnostics, Inc. | 06/08/2026Open, Classified |
| Z-2699-2026 Class II | KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,A product error defect may cause incorrect bracket placement. | Klowen Braces | 06/08/2026Open, Classified |
| Z-2677-2026 Class II | Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RSurgical dressing manufactured out of specification (greater thickness). | ConvaTec, Inc | 06/08/2026Open, Classified |
| Z-2648-2026 Class II | ARTIS icono ceiling. Model Number: 11328100.Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time… | Siemens Medical Solutions USA, Inc | 06/08/2026Open, Classified |
| Z-2749-2026 Class I | MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2)…Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits… | Medline Industries, LP | 06/05/2026Open, Classified |
| Z-2748-2026 Class I | MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION…Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits… | Medline Industries, LP | 06/05/2026Open, Classified |
| Z-2747-2026 Class I | MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640GMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits… | Medline Industries, LP | 06/05/2026Open, Classified |
| Z-2728-2026 Class II | Optima XR240amx, Mobile Digital Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-2727-2026 Class II | Optima XR220amx, Mobile Digital-Ready Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-2726-2026 Class II | Optima XR200amx, Mobile Digital-Ready Radiographic SystemGE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column… | GE Medical Systems, LLC | 06/05/2026Open, Classified |
| Z-2714-2026 Class II | OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences… | Integra LifeSciences Corp. (NeuroSciences) | 06/05/2026Open, Classified |
| Z-2676-2026 Class II | Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III…Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous… | Olympus Corporation of the Americas | 06/05/2026Open, Classified |
| Z-2645-2026 Class II | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog…May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus… | Medela Inc | 06/05/2026Open, Classified |
| Z-2579-2026 Class II | Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following…Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device… | Philips North America Llc | 06/05/2026Open, Classified |
| Z-2916-2026 Class II | Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102…Due to off-the-shelf display port component that has audio/video failures | Spacelabs Healthcare, Inc. | 06/04/2026Open, Classified |
| Z-2715-2026 Class II | VITEK 2 AST-N447 TEST KIT Product reference 424620Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from… | Biomerieux Inc | 06/04/2026Open, Classified |
| Z-2654-2026 Class II | MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461…Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market. | BD Switzerland Sarl | 06/04/2026Open, Classified |