Class I Medical Device Recalls
Class I recalls are the most serious: there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-2709-2026 Class I | Bone Marrow Tray, REF: CB0033TL; CB0355TLAKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2708-2026 Class I | Arterial Line Kit 20ga x 6, REF: 400115AKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2707-2026 Class I | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2706-2026 Class I | General Biospy Tray, REF: GUTS1000Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2705-2026 Class I | One-Piece Introducer Tray, REF: 497455, 497434 cardiovascularKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2704-2026 Class I | Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A…Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2463-2026 Class I | Breathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with…Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body… | Hamilton Medical AG | 05/29/2026Open, Classified |
| Z-2624-2026 Class I | Medtronic Harmony Delivery Catheter SystemDevices containing inner shaft assemblies from specific manufacturing lots may have an increased potential… | Medtronic Heart Valves Division | 05/22/2026Open, Classified |
| Z-2602-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2601-2026 Class I | Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2600-2026 Class I | Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2599-2026 Class I | Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product…Potential for thrombus formation during prolonged use of the introducer. | Abiomed, Inc. | 05/22/2026Open, Classified |
| Z-2622-2026 Class I | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… | Windstone Medical Packaging, Inc. | 05/21/2026Open, Classified |
| Z-2621-2026 Class I | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… | Windstone Medical Packaging, Inc. | 05/21/2026Open, Classified |
| Z-2620-2026 Class I | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… | Windstone Medical Packaging, Inc. | 05/21/2026Open, Classified |
| Z-2619-2026 Class I | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical…Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of… | Windstone Medical Packaging, Inc. | 05/21/2026Open, Classified |
| Z-2551-2026 Class I | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog…There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system… | Baxter Healthcare Corporation | 05/21/2026Open, Classified |
| Z-2550-2026 Class I | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog…There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system… | Baxter Healthcare Corporation | 05/21/2026Open, Classified |
| Z-2549-2026 Class I | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number…There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system… | Baxter Healthcare Corporation | 05/21/2026Open, Classified |
| Z-2548-2026 Class I | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number…There have been reports of air and medication leakage from the nebulizer cup during therapy of Volara system… | Baxter Healthcare Corporation | 05/21/2026Open, Classified |
| Z-2605-2026 Class I | Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD-…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-2604-2026 Class I | Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-2603-2026 Class I | Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2.…External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of… | Insulet Corporation | 05/20/2026Open, Classified |
| Z-2457-2026 Class I | Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in… | Abiomed, Inc. | 05/18/2026Open, Classified |
| Z-2615-2026 Class I | Reprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St.…Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual… | Medline Industries, LP | 05/15/2026Open, Classified |
| Z-2360-2026 Class I | Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled…Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left… | Abiomed, Inc. | 05/14/2026Open, Classified |
| Z-2792-2026 Class I | Pack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic…Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate… | Medical Action Industries, Inc. 306 | 05/13/2026Open, Classified |
| Z-2359-2026 Class I | Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-2358-2026 Class I | Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-2357-2026 Class I | Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator…Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver… | Datex-Ohmeda Inc | 05/08/2026Open, Classified |
| Z-2208-2026 Class I | Atlan A350XL. Model Number: 8621600. anesthesia workstationThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered… | Draeger, Inc. | 05/07/2026Open, Classified |
| Z-2207-2026 Class I | Atlan A350. Model Number: 8211500. anesthesia workstationThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered… | Draeger, Inc. | 05/07/2026Open, Classified |
| Z-2455-2026 Class I | Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC010890; 2)…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… | Medline Industries, LP | 05/06/2026Open, Classified |
| Z-2454-2026 Class I | Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO, Model Number: ACC011142; 2)…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… | Medline Industries, LP | 05/06/2026Open, Classified |
| Z-2453-2026 Class I | Medline Convenience Kits: 1) OPEN HEART CDS, Model Number: CDS840144Q; 2) OPEN HEART…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… | Medline Industries, LP | 05/06/2026Open, Classified |
| Z-2452-2026 Class I | Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM SET UP; 2)…The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP… | Medline Industries, LP | 05/06/2026Open, Classified |
| Z-2278-2026 Class I | Design Options Spinal Tray Spinal Needle Anesthesia procedure kits: Material Description…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |
| Z-2277-2026 Class I | Spinocan Spinal Needle procedure kits: Material Description (Material Number): Spinocan…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |
| Z-2276-2026 Class I | Spinal Needle procedure kits: Material Description (Material Number) 24GA. PENCAN SPINAL…These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the… | B Braun Medical Inc | 05/06/2026Open, Classified |
| Z-2224-2026 Class I | Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP… | Fresenius Kabi USA, LLC | 05/06/2026Open, Classified |
| Z-2223-2026 Class I | LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%)… | Fresenius Kabi USA, LLC | 05/06/2026Open, Classified |
| Z-2212-2026 Class I | Pediatric care bed; Product Designation: KayserBett IDA;If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the… | Kayserbetten GmbH & Co. KG | 05/04/2026Open, Classified |
| Z-2798-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2797-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2796-2026 Class I | Halyard convenience kits containing recalled Medline Namic Angiographic Star Off Handle…Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the… | AVID Medical, Inc. | 04/30/2026Open, Classified |
| Z-2257-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2256-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2255-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2254-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in.; lidocaine HCL (1%), 2 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2253-2026 Class I | BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke Needle 22 G x 3.5 in.…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2252-2026 Class I | BDSpinal Tray with BDWhitacre Needle 24 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2251-2026 Class I | BDSpinal Tray with BDWhitacre Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2250-2026 Class I | BDSpinal Tray with BDQuincke Needle 26 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2249-2026 Class I | BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2248-2026 Class I | BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in.; lidocaine HCL (1%), 5 mL…This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride… | Becton Dickinson & Company | 04/27/2026Open, Classified |
| Z-2160-2026 Class I | RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U…Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent… | Bolton Medical Inc. | 04/22/2026Open, Classified |
| Z-2397-2026 Class I | Description/REF: RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A; RA CATH KIT: 20 GA X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2396-2026 Class I | Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2395-2026 Class I | Description/REF: PICC ACCESS TRAY/ASK-04001-CG1Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2394-2026 Class I | Description/REF: MIDLINE CATHETER KIT: 3 FR X 20 CM/CDC-02031-MK1A; AM/AT PI MIDLINE 1L:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2393-2026 Class I | Description/REF: PSI KIT: 7 FR X 4 IN/ASK-09701-UP; PSI KIT: 8.5 FR X 4 1/8 IN (10…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2392-2026 Class I | Description/REF: ACCESS TRAY/ASK-04001-MC3Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2391-2026 Class I | Description/REF: RA CATH KIT: 20 GA X 1-3/4IN/AK-04020-SPC; RA CATH KIT: 20 GA X 5…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2390-2026 Class I | Description/REF: SAC KIT: 18 GA X 12CM W BIO/SAC-01218-B; SAC KIT: 18 GA X 12CM W…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2389-2026 Class I | Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2388-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 20 CM/AK-15122-F, AHDC KIT: 3L 12 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2387-2026 Class I | Description/REF: PI MIDLINE 2L: 5FR X 20CM/CDC-32052-MPKCLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2386-2026 Class I | Description/REF: PARACENTESIS KIT/ASK-00376-JHHLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2385-2026 Class I | Description/REF: ACCESS TRAY/GU-04020; PSI KIT: 8.5 FR/AK-09803-CDC; PSI KIT: 9…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2384-2026 Class I | Description/REF: ACCESS TRAY/ASK-04001-JHH; ACCESS TRAY/ASK-04001-LMDTG; PI CVC KIT: 3…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2383-2026 Class I | Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGULidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2382-2026 Class I | Description/REF: DRAINAGE KIT/AK-01600, DRAINAGE KIT/AK-01601, DRAINAGE…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2381-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 12 FR X 16 CM/AK-12122-FLidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2380-2026 Class I | Description/REF: PERITONEAL LAVAGE CATH KIT:8FR/AK-09000Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2379-2026 Class I | Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2378-2026 Class I | Description/REF: PI PICC: 3: 6FR x 55CM w CHG/ DLX-35563-HPKC; AGBA PICC: 2L 5.5 FR X 45…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2377-2026 Class I | Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2376-2026 Class I | Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH; CVC KIT: 3-LUMEN 12 FR…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2375-2026 Class I | Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2; PI CVC KIT: 3L 7 FR X…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2374-2026 Class I | Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC; AHDC KIT: 3-L 12 FR X 20…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2373-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F; HEMODIALYSIS KIT:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2372-2026 Class I | Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1ALidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2371-2026 Class I | Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1; EPIDURAL…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2370-2026 Class I | Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA:…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2369-2026 Class I | Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH; PSI KIT: 8.5 FR X 4…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2368-2026 Class I | Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1; RA CATH KIT: 20 GA X 1…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2367-2026 Class I | Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB; AGBA PICC G4…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2366-2026 Class I | Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2365-2026 Class I | Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2364-2026 Class I | Description/REF: ACCESS TRAY/ASK-04001-SUH-S; ACCESS TRAY/ASK-04001-VM1; STIMUCATH SFTY…Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2363-2026 Class I | PARACENTESIS KIT, REF: AK-00376, ASK-00376-VCULidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2211-2026 Class I | Automated Impella Controller (AIC); Product Code: 0042-0000-US;A retrospective review identified that there are AIC units requiring specific hardware updates to address… | Abiomed, Inc. | 04/20/2026Open, Classified |
| Z-2237-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2236-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2235-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2234-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2233-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2232-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2231-2026 Class I | Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled…Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which… | Medline Industries, LP | 04/10/2026Open, Classified |
| Z-2159-2026 Class I | NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX…16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted… | Arrow International, LLC | 04/10/2026Open, Classified |
| Z-2158-2026 Class I | Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP…16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted… | Arrow International, LLC | 04/10/2026Open, Classified |
| Z-2157-2026 Class I | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter: REF: ACS-15192-VFI…16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted… | Arrow International, LLC | 04/10/2026Open, Classified |
| Z-2156-2026 Class I | Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted… | Arrow International, LLC | 04/10/2026Open, Classified |
| Z-2066-2026 Class I | Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes…Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of… | Windstone Medical Packaging, Inc. | 04/02/2026Open, Classified |
| Z-1936-2026 Class I | Beacon Tip Centimeter Sizing Catheter RPN/GPN NR5.0-35-70-P-10S-0-CSC-20 G31213…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1935-2026 Class I | Aurous Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20-01 GPN G47308 Sizing…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1934-2026 Class I | Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-PIG-CSC-20 GPN G11916 Catheters for use…Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result… | Cook Incorporated | 04/02/2026Open, Classified |
| Z-1947-2026 Class I | AIDBAGs are first aid kits of convenience composed of individually labeled devices…Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been… | North American Rescue LLC. | 03/27/2026Open, Classified |
| Z-2047-2026 Class I | Rolls of label stock used with the Omnicell i.v.Station. 1. Part Number 258920028…Potential for mislabeled syringe produced by the i.v.STATION device. | Omnicell, Inc. | 03/25/2026Open, Classified |
| Z-1942-2026 Class I | VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000Respiratory system intended to provide continuous/intermittent ventilator support, may not have been… | Ventec Life Systems, Inc. | 03/25/2026Open, Classified |
| Z-2148-2026 Class I | Medline medical convenience kits, containing Namic Manifold, Labeled as: TAVI, Medline…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2147-2026 Class I | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1.…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2146-2026 Class I | Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART CATH…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2145-2026 Class I | 1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Medline Kit…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2144-2026 Class I | 1. DBD-MTS,3V,MAN,KIT, Medline Kit Number/SKU 60010195; 2. MTS-LEFT HEART,KIT, Medline…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2143-2026 Class I | Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. ANGIOGRAPHY…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2142-2026 Class I | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2141-2026 Class I | Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravascular…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2140-2026 Class I | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2139-2026 Class I | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-2138-2026 Class I | Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200…Medline has identified the presence of particulate within the fluid path of the Manifolds. | Medline Industries, LP | 03/24/2026Open, Classified |
| Z-1981-2026 Class I | Convenience kits containing Medline Namic Angiographic Control Syringes with Rotating…Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during… | American Contract Systems Inc | 03/19/2026Open, Classified |
| Z-1803-2026 Class I | B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1802-2026 Class I | B. Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 2.6MM PUMP SEGMENT. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1801-2026 Class I | B. Barun Hemodialysis Bloodlines, StreamLine Bloodline Long Version, FMC. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1800-2026 Class I | B. Braun Hemodialysis Bloodlines, STREAMLINE FRESENIUS FOR DAVITA. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1799-2026 Class I | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1798-2026 Class I | B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number:…Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to… | B Braun Medical Inc | 03/19/2026Open, Classified |
| Z-1771-2026 Class I | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of… | Boston Scientific Corporation | 03/19/2026Open, Classified |
| Z-1770-2026 Class I | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac…Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of… | Boston Scientific Corporation | 03/19/2026Open, Classified |
| Z-2007-2026 Class I | Medical Action Industries Inc. Pack Cath BHH, REF: BHCA49K, Sterile EO, Rx Only, QTY:…Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose… | Medical Action Industries, Inc. 306 | 03/17/2026Open, Classified |
| Z-1979-2026 Class I | Halyard VA DETROIT CATH LAB PACK kit. Model Numbers: VMCD029.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1978-2026 Class I | Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1977-2026 Class I | Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1976-2026 Class I | Halyard NEURO IR PERIPHERAL (PS 64405) kit. Model Number: UINR44-01.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1975-2026 Class I | Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1974-2026 Class I | Halyard CATH LAB kit. Model Number: SACL75-01.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1973-2026 Class I | Halyard CATH LAB kit. Model Number: SACL75AM.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1972-2026 Class I | Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1971-2026 Class I | Halyard CARDIAC CATH PACK SAN23CARDQ kit. Model Number: DRCC36.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1970-2026 Class I | Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose… | AVID Medical, Inc. | 03/13/2026Open, Classified |
| Z-1797-2026 Class I | Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that… | Insulet Corporation | 03/12/2026Open, Classified |
| Z-1855-2026 Class I | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | Intuitive Surgical, Inc. | 03/11/2026Open, Classified |
| Z-1649-2026 Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous…In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1648-2026 Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use…In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1647-2026 Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use…In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1646-2026 Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use…In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1617-2026 Class I | Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous…Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1616-2026 Class I | Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-use…Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1615-2026 Class I | Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use…Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1614-2026 Class I | Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use…Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the… | Philips Respironics, Inc. | 03/02/2026Open, Classified |
| Z-1730-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1729-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1728-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1727-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1726-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1725-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1724-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1723-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1722-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1721-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1720-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1719-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1718-2026 Class I | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1717-2026 Class I | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1716-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1715-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1714-2026 Class I | Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA)…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1713-2026 Class I | NAMIC Angiographic Control Syringe, labeled as follows: 1.…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1712-2026 Class I | NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline…Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe… | Medline Industries, LP | 02/27/2026Open, Classified |
| Z-1637-2026 Class I | Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937.…Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that… | Baxter Healthcare Corporation | 02/18/2026Open, Classified |
| Z-1589-2026 Class I | Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and…Increased risk of purge leaks with Generation 1 purge cassettes. | Abiomed, Inc. | 02/18/2026Open, Classified |
| Z-1588-2026 Class I | Handy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico…If heating pad is folded while in use, the power density increases in the folded area causing excessive… | Navajo Manufacturing Company | 02/18/2026Open, Classified |
| Z-1591-2026 Class I | Automated Impella Controller (AIC), labeled as the following with corresponding Product…Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be… | Abiomed, Inc. | 02/16/2026Open, Classified |
| Z-1579-2026 Class I | BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU…16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-1578-2026 Class I | DuraMax Chronic Hemodialysis Catheter, REF: H787103028015/A, H787103028025/A…16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-1577-2026 Class I | 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile), REF: FCL-174-00/B16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-1576-2026 Class I | ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C…16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-1575-2026 Class I | CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A…16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may… | Merit Medical Systems, Inc. | 02/13/2026Open, Classified |
| Z-1568-2026 Class I | Flexible Cryoprobe (OD 2.4mm, L1.15mm) REF: 20402-411. For surgical useProbes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-1567-2026 Class I | Flexible Cryoprobe (OD 1.7mm, L1.15mm) REF: 20402-410. For surgical useProbes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-1566-2026 Class I | Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401…Probes may rupture/burst during activation | Erbe USA Inc | 02/12/2026Open, Classified |
| Z-1548-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1547-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1546-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1545-2026 Class I | Owner's Booklets and Instructions for Use that are used with the following blood glucose…The system labeling (user manual and online labeling) did not provide adequate directions for lay users to… | Trividia Health, Inc. | 02/06/2026Open, Classified |
| Z-1471-2026 Class I | Impella RP. Product Code: 0046-0011.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Abiomed, Inc. | 01/27/2026Open, Classified |
| Z-1470-2026 Class I | Impella RP Flex with SmartAssist. Product Code: 1000323.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Abiomed, Inc. | 01/27/2026Open, Classified |
| Z-1469-2026 Class I | Impella RP with SmartAssist. Product Code: 0046-0035.Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift. | Abiomed, Inc. | 01/27/2026Open, Classified |
| Z-1354-2026 Class I | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1353-2026 Class I | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1352-2026 Class I | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the…Issue with software algorithm which may lead to overpressure events. | Olympus Corporation of the Americas | 01/16/2026Open, Classified |
| Z-1827-2026 Class I | WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an…Cyber vulnerability of BLE communication was found by CISA VDP program. | Whill, Inc. | 12/29/2025Open, Classified |
| Z-1826-2026 Class I | WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an…Cyber vulnerability of BLE communication was found by CISA VDP program. | Whill, Inc. | 12/29/2025Open, Classified |
| Z-1325-2026 Class I | Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1324-2026 Class I | Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1323-2026 Class I | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE Catheter 9F x…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1322-2026 Class I | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St.…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1321-2026 Class I | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1320-2026 Class I | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquiry Steerable…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1319-2026 Class I | Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 Electrodes…These lots of reprocessed catheters may contain small particles of residual material. If affected devices… | Medline Industries, LP | 12/22/2025Open, Classified |
| Z-1163-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1162-2026 Class I | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1161-2026 Class I | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1160-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1159-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1158-2026 Class I | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number…Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable… | Boston Scientific Corporation | 12/19/2025Open, Classified |
| Z-1117-2026 Class I | Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog…Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | SunMed Holdings, LLC | 12/15/2025Open, Classified |
| Z-1116-2026 Class I | Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer…Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | SunMed Holdings, LLC | 12/15/2025Open, Classified |
| Z-1115-2026 Class I | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape…Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | SunMed Holdings, LLC | 12/15/2025Open, Classified |
| Z-1114-2026 Class I | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape…Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | SunMed Holdings, LLC | 12/15/2025Open, Classified |
| Z-1016-2026 Class I | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LOMedline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1015-2026 Class I | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003LMedline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1014-2026 Class I | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELOMedline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1013-2026 Class I | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full…Medline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1012-2026 Class I | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002LMedline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1011-2026 Class I | MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi…Medline Industries has identified a potential hazard involving the hand control pendant and associated… | Medline Industries, LP | 11/26/2025Open, Classified |
| Z-1023-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | Abbott Diabetes Care, Inc. | 11/24/2025Open, Classified |
| Z-1022-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | Abbott Diabetes Care, Inc. | 11/24/2025Open, Classified |
| Z-1021-2026 Class I | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | Abbott Diabetes Care, Inc. | 11/24/2025Open, Classified |
| Z-1020-2026 Class I | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3…Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in… | Abbott Diabetes Care, Inc. | 11/24/2025Open, Classified |
| Z-0939-2026 Class I | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers:…Ophthalmic procedure packs may have incomplete seals affecting sterility. | Alcon Research LLC | 11/24/2025Open, Classified |
| Z-0934-2026 Class I | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities. | Draeger, Inc. | 11/24/2025Open, Classified |
| Z-0933-2026 Class I | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities. | Draeger, Inc. | 11/24/2025Open, Classified |
| Z-0915-2026 Class I | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field…Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power… | GE Medical Systems China Co., Ltd. | 11/14/2025Open, Classified |
| Z-0914-2026 Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation…Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power… | GE Medical Systems China Co., Ltd. | 11/14/2025Open, Classified |
| Z-0913-2026 Class I | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation…Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing certain power… | GE Medical Systems China Co., Ltd. | 11/14/2025Open, Classified |
| Z-0885-2026 Class I | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled…Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm… | Fresenius Kabi USA, LLC | 11/14/2025Open, Classified |
| Z-1002-2026 Class I | Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08Devices are not suitable for organ transplant. | AVID Medical, Inc. | 11/11/2025Open, Classified |
| Z-1001-2026 Class I | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.Devices are not suitable for organ transplant. | AVID Medical, Inc. | 11/11/2025Open, Classified |
| Z-1000-2026 Class I | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.Devices are not suitable for organ transplant. | AVID Medical, Inc. | 11/11/2025Open, Classified |
| Z-0593-2026 Class I | ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0592-2026 Class I | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0591-2026 Class I | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0590-2026 Class I | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of…Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Draeger, Inc. | 11/10/2025Open, Classified |
| Z-0586-2026 Class I | IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing…Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient… | Fresenius Kabi USA, LLC | 11/03/2025Open, Classified |
| Z-0570-2026 Class I | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog…Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to… | Olympus Corporation of the Americas | 10/30/2025Open, Classified |
| Z-0430-2026 Class I | BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437…If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can… | CareFusion 303, Inc. | 10/17/2025Open, Classified |
| Z-0488-2026 Class I | TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx OnlyPatient-fitted temporomandibular joint implant contained discrepancy in screw hole position. | TMJ Solutions Inc | 10/13/2025Open, Classified |
| Z-0451-2026 Class I | Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0450-2026 Class I | Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATEFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0449-2026 Class I | Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0448-2026 Class I | Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0447-2026 Class I | Convenience Kit, BREAST HERNIA DYNJ909125GFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0446-2026 Class I | DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0445-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0444-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0443-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0442-2026 Class I | Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; Product…Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing.… | Medline Industries, LP | 10/10/2025Open, Classified |
| Z-0532-2026 Class I | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH…The impacted lot may not meet the required tensile strength specification. | Glycar SA Pty., Ltd. | 10/09/2025Open, Classified |
| Z-0531-2026 Class I | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914; PATCH…The impacted lot may not meet the required tensile strength specification. | Glycar SA Pty., Ltd. | 10/09/2025Open, Classified |
| Z-0427-2026 Class I | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated…Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions.… | Tandem Diabetes Care, Inc. | 10/06/2025Open, Classified |
| Z-0434-2026 Class I | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM…Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke… | Cerenovus Inc | 10/02/2025Open, Classified |
| Z-0154-2026 Class I | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer…IV Gravity burette administration set burette component is missing an internal shutoff valve intended to… | ICU Medical, Inc. | 10/02/2025Open, Classified |
| Z-0431-2026 Class I | MAGNETOM Cima.X Upgrade. Model Number: 11689304.There is a potential for an ice blockage to form or currently exist within the primary and/or the auxiliary… | Siemens Medical Solutions USA, Inc | 10/01/2025Open, Classified |
| Z-0069-2026 Class I | Automated Impella Controller (AIC), used for left heart support blood pump, labeled as…Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller… | Abiomed, Inc. | 10/01/2025Open, Classified |
| Z-0164-2026 Class I | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI…There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | IMPRIS Imaging Inc | 09/30/2025Open, Classified |
| Z-0163-2026 Class I | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDAThere is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | IMPRIS Imaging Inc | 09/30/2025Open, Classified |
| Z-0162-2026 Class I | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, SkyraThere is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | IMPRIS Imaging Inc | 09/30/2025Open, Classified |
| Z-0161-2026 Class I | IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla…There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system… | IMPRIS Imaging Inc | 09/30/2025Open, Classified |
| Z-0070-2026 Class I | Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG…The potential for micro-air bubbles observed in the bloodline and air-in-line alarms due to damaged arterial… | B Braun Medical Inc | 09/30/2025Open, Classified |
| Z-0374-2026 Class I | CODMAN Disposable Perforator 9mm. Cranial Perforator.Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm… | Integra LifeSciences Corp. (NeuroSciences) | 09/26/2025Open, Classified |
| Z-0373-2026 Class I | CODMAN Disposable Perforator 11mm. Cranial Perforator.Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm… | Integra LifeSciences Corp. (NeuroSciences) | 09/26/2025Open, Classified |
| Z-0188-2026 Class I | Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog…Due to an identified manufacturing defect involving coating material lifting within the catheter's distal… | Balt USA, LLC | 09/25/2025Open, Classified |
| Z-0043-2026 Class I | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers…Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment… | Cook Medical Incorporated | 09/18/2025Open, Classified |
| Z-0031-2026 Class I | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20…IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in… | Percussionaire Corporation | 09/17/2025Open, Classified |
| Z-0136-2026 Class I | Automated Impella Controller (AIC) labeled as the following with corresponding Product…Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures. | Abiomed, Inc. | 09/16/2025Open, Classified |
| Z-0067-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0066-2026 Class I | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0065-2026 Class I | EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0064-2026 Class I | BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0063-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0062-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-ACAdditional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0061-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0060-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0059-2026 Class I | BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0058-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0057-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0056-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0055-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0054-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0053-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0052-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0051-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0050-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0049-2026 Class I | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0048-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0047-2026 Class I | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0046-2026 Class I | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0045-2026 Class I | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used… | Olympus Corporation of the Americas | 09/11/2025Open, Classified |
| Z-0035-2026 Class I | BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing…Infusion pump module used with compatible pump infusion sets may perform outside the established performance… | CareFusion 303, Inc. | 09/11/2025Open, Classified |
| Z-0113-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | Abbott | 09/10/2025Open, Classified |
| Z-0112-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | Abbott | 09/10/2025Open, Classified |
| Z-0111-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | Abbott | 09/10/2025Open, Classified |
| Z-0110-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | Abbott | 09/10/2025Open, Classified |
| Z-0109-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | Abbott | 09/10/2025Open, Classified |
| Z-2617-2025 Class I | Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software…The device either indicated a failure of the piston ventilator before use or suffered a failure of the… | Draeger, Inc. | 09/09/2025Open, Classified |
| Z-2616-2025 Class I | Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software…The device either indicated a failure of the piston ventilator before use or suffered a failure of the… | Draeger, Inc. | 09/09/2025Open, Classified |
| Z-0029-2026 Class I | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IThe unexpected internal fault / system diagnostic error to result when a rapid succession of button… | Noxbox Ltd | 09/09/2025Open, Classified |
| Z-0028-2026 Class I | NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-IFluctuations may be more likely to occur if the total flow through the device sensor (used by the device to… | Noxbox Ltd | 09/09/2025Open, Classified |
| Z-2668-2025 Class I | MAGNETOM Vida Fit. Model Number: 11410481.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2667-2025 Class I | MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254…There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2666-2025 Class I | MAGNETOM Verio Dot Upgrade. Model Number: 10684334.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2665-2025 Class I | MAGNETOM Verio Dot. Model Number: 10684333.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2664-2025 Class I | MAGNETOM Verio. Model Number: 10276755.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2663-2025 Class I | MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2.…There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2662-2025 Class I | MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2661-2025 Class I | MAGNETOM Skyra fit. Model Number: 10849580.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2660-2025 Class I | MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510…There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2659-2025 Class I | MAGNETOM Prisma. Model Number: 10849582.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2658-2025 Class I | MAGNETOM Lumina (DE). Model Number: 11344916.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2657-2025 Class I | MAGNETOM Connectom.X. Model Number: 11371480.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2656-2025 Class I | MAGNETOM Cima.X (DE). Model Number: 11647158.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2655-2025 Class I | BIOGRAPH One (DE). Model Number: 11689172.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-2654-2025 Class I | Biograph mMR. Model Number: 10433372.There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the… | Siemens Medical Solutions USA, Inc | 08/28/2025Open, Classified |
| Z-0318-2026 Class I | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and…A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly… | Dexcom, Inc. | 08/28/2025Open, Classified |
| Z-2670-2025 Class I | Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-LF, Model…The kits contain certain lots of cannula products where the catheter may not retain its shape. | Medline Industries, LP | 08/21/2025Open, Classified |
| Z-2568-2025 Class I | Automated Impella Controller (AIC) with the below brands and product codes. Used with…Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current… | Abiomed, Inc. | 08/20/2025Open, Classified |
| Z-0105-2026 Class I | Model Number U228, VISIONIST CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0104-2026 Class I | Model Number U226, VISIONIST CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0103-2026 Class I | Model Number U225 VISIONIST CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0102-2026 Class I | Model Number U128, VALITUDE CRT-P EL MRISoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0101-2026 Class I | Model Number U125, VALITUDE CRT-P ELSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0100-2026 Class I | Model Number S722, ALTRUA 2 DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0099-2026 Class I | Model Number S702, ALTRUA 2 DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0098-2026 Class I | Model Number S701 ALTRUA 2 SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0097-2026 Class I | Model Number L131, ESSENTIO DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0096-2026 Class I | Model Number L121 ESSENTIO DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0095-2026 Class I | Model Number L111, ESSENTIO DR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0094-2026 Class I | Model Number L110, ESSENTIO SR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0093-2026 Class I | Model Number L101, ESSENTIO DR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0092-2026 Class I | Model Number L100, ESSENTIO SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0091-2026 Class I | Model Number L231, PROPONENT DR EL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0090-2026 Class I | Model Number L221 PROPONENT DR EL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0089-2026 Class I | Model Number L211 PROPONENT DR SL MRI PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0088-2026 Class I | Model Number L210 PROPONENT SR SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0087-2026 Class I | Model Number L209 PROPONENT DR (VDD) SL PacemakerSoftware to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0086-2026 Class I | PROPONENT DR SL (Model L201)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0085-2026 Class I | PROPONENT SR SL (Model L200)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0084-2026 Class I | ACCOLADE DR EL MRI (Model L331)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0083-2026 Class I | ACCOLADE DR EL (Model L321)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0082-2026 Class I | ACCOLADE DR SL MRI (Model L311)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0081-2026 Class I | ACCOLADE SR SL MRI (Model L310)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0080-2026 Class I | ACCOLADE DR SL (Model L301)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-0079-2026 Class I | ACCOLADE SR SL (Model L300)Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an… | Boston Scientific Corporation | 08/20/2025Open, Classified |
| Z-2540-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2539-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCK use in…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2538-2025 Class I | Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC use in conjunction…Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a… | Max Mobility LLC | 08/12/2025Open, Classified |
| Z-2593-2025 Class I | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701BConvenience kits labeled as sterile have not gone through the sterilization process. | Medline Industries, LP | 08/08/2025Open, Classified |
| Z-2592-2025 Class I | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB…Convenience kits labeled as sterile have not gone through the sterilization process. | Medline Industries, LP | 08/08/2025Open, Classified |
| Z-2484-2025 Class I | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot…Potential for undetected, deformed a-traumatic tips. | Olympus Corporation of the Americas | 08/06/2025Open, Classified |
| Z-2482-2025 Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT…The catheters may not retain their shape. | Medtronic Perfusion Systems | 08/06/2025Open, Classified |
| Z-2481-2025 Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT…The catheters may not retain their shape. | Medtronic Perfusion Systems | 08/06/2025Open, Classified |
| Z-2480-2025 Class I | DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT…The catheters may not retain their shape. | Medtronic Perfusion Systems | 08/06/2025Open, Classified |
| Z-2334-2025 Class I | Novum IQ Syringe Pump, Product Code 40700BAX, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2333-2025 Class I | Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2332-2025 Class I | Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pumpBaxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume… | Baxter Healthcare Corporation | 08/04/2025Open, Classified |
| Z-2614-2025 Class I | Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-luminal…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2613-2025 Class I | Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2612-2025 Class I | Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording and cardiac…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2611-2025 Class I | Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2610-2025 Class I | Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH…Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual… | Medline Industries, LP | 07/31/2025Open, Classified |
| Z-2436-2025 Class I | WATCHMAN TruSteer Access System, US, Material Number (UPN) M635TU90050;intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2435-2025 Class I | WATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2434-2025 Class I | WATCHMAN FXD Curve Access System Sgl, US, Material Number (UPN) M635TU80010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2433-2025 Class I | WATCHMAN TruSeal Access System ANT, US, Material Number (UPN) M635TU70040; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2432-2025 Class I | WATCHMAN TruSeal Access System DBL, US, Material Number (UPN) M635TU70020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2431-2025 Class I | WATCHMAN TruSeal Access System SGL, US, Material Number (UPN) M635TU70010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2430-2025 Class I | WATCHMAN FXD Curve Access Sys Dbl, OUS, Material Number (UPN) M635TS80020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2429-2025 Class I | WATCHMAN FXD Curve Access Sys Sgl, OUS, Material Number (UPN) M635TS80010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2428-2025 Class I | WATCHMAN TruSeal Access System ANT, OUS, Material Number (UPN) M635TS70040; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2427-2025 Class I | WATCHMAN TruSeal Access System DBL, OUS, Material Number (UPN) M635TS70020; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2426-2025 Class I | WATCHMAN TruSeal Access System SGL, OUS, Material Number (UPN) M635TS70010; intended to…Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed… | Boston Scientific Corporation | 07/29/2025Open, Classified |
| Z-2567-2025 Class I | Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT, Kit Number…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | MEDLINE INDUSTRIES, LP - Northfield | 07/25/2025Open, Classified |
| Z-2566-2025 Class I | Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit Number…Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing… | MEDLINE INDUSTRIES, LP - Northfield | 07/25/2025Open, Classified |
| Z-2450-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | Dexcom, Inc. | 07/24/2025Open, Classified |
| Z-2449-2025 Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | Dexcom, Inc. | 07/24/2025Open, Classified |
| Z-2448-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | Dexcom, Inc. | 07/24/2025Open, Classified |
| Z-2447-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | Dexcom, Inc. | 07/24/2025Open, Classified |
| Z-2446-2025 Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM…The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS… | Dexcom, Inc. | 07/24/2025Open, Classified |
| Z-2327-2025 Class I | RELIANCE 4-FRONT, endocardial cardioversion/defibrillation and pace/sense lead…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | Boston Scientific Corporation | 07/24/2025Open, Classified |
| Z-2326-2025 Class I | ENDOTAK RELIANCE G/SG with 4-SITE Connector, transvenous defibrillation lead, Permanent…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | Boston Scientific Corporation | 07/24/2025Open, Classified |
| Z-2325-2025 Class I | ENDOTAK RELIANCE G/SG, transvenous defibrillation lead, implantable cardioverter…Affected lead models may experience gradually rising LVSI measurements in association with calcification of… | Boston Scientific Corporation | 07/24/2025Open, Classified |
| Z-2343-2025 Class I | Battery Operated infusion pumps. t:slim X2 G5, Replacement, Refurbished, REF: 1000911…Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which… | Tandem Diabetes Care, Inc. | 07/21/2025Open, Classified |
| Z-2460-2025 Class I | Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic…Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. | MEDLINE INDUSTRIES, LP - Northfield | 07/14/2025Open, Classified |
| Z-2173-2025 Class I | Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSBaxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the… | Baxter Healthcare Corporation | 07/14/2025Open, Classified |
| Z-2187-2025 Class I | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2186-2025 Class I | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2185-2025 Class I | Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2184-2025 Class I | BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415ULaryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2183-2025 Class I | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U…Laryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2182-2025 Class I | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1)…Laryngoscope handles may not illuminate as intended. | Flexicare Medical (Dongguan) Ltd. | 07/11/2025Open, Classified |
| Z-2129-2025 Class I | Plum Duo Infusion System, List Number: 400020401ICU Medical identified two sequences of programming events and alarm interactions that may cause the user… | ICU Medical, Inc. | 07/11/2025Open, Classified |
| Z-2459-2025 Class I | IDM-ARLITE-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2458-2025 Class I | All-round Joystick R-net Light. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2457-2025 Class I | IDM-MULTI-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2456-2025 Class I | IDM-MICRO-R. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2455-2025 Class I | Multi Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2454-2025 Class I | Micro Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which… | mo-Vis BVBA | 07/10/2025Open, Classified |
| Z-2181-2025 Class I | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog…Potential for the manometer port being blocked rendering the manometer non-functional. | Ambu Inc. | 07/09/2025Open, Classified |
| Z-2176-2025 Class I | Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV…Label is incorrect. The product label indicates that the device contains an air eliminating filter. However… | B Braun Medical Inc | 07/09/2025Open, Classified |
| Z-2180-2025 Class I | BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check…Infusion pump module used with compatible pump infusion sets may perform outside the established performance… | CareFusion 303, Inc. | 07/08/2025Open, Classified |
| Z-2179-2025 Class I | BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsInfusion pump module used with compatible pump infusion sets may perform outside the established performance… | CareFusion 303, Inc. | 07/08/2025Open, Classified |
| Z-2273-2025 Class I | Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and…Certain batches are being removed due to an increase in complaints received in which physicians encountered… | Boston Scientific Corporation | 07/07/2025Open, Classified |
| Z-2229-2025 Class I | DreamStation Auto. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration. | Philips Respironics, Inc. | 06/30/2025Open, Classified |
| Z-2228-2025 Class I | DreamStation Auto BiPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration. | Philips Respironics, Inc. | 06/30/2025Open, Classified |
| Z-2227-2025 Class I | DreamStation Auto CPAP. Non-Continuous Ventilator.Devices may possess a programming error resulting in an incorrect device configuration. | Philips Respironics, Inc. | 06/30/2025Open, Classified |
| Z-2167-2025 Class I | Breathing circuit set, coaxial, 1.80 m, with flow sensor and expiratory valve set, REF:…Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to… | Hamilton Medical AG | 06/26/2025Open, Classified |
| Z-2291-2025 Class I | Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754…Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism… | Thoratec LLC | 06/23/2025Open, Classified |
| Z-2290-2025 Class I | Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog…Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism… | Thoratec LLC | 06/23/2025Open, Classified |
| Z-2164-2025 Class I | Automated Impella Controller (AIC), used in left heart support blood pump, including the…A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is… | Abiomed, Inc. | 06/23/2025Open, Classified |
| Z-2096-2025 Class I | Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2Certain Spectrum infusion pumps may have an incorrect version of software. | Baxter Healthcare Corporation | 06/20/2025Open, Classified |
| Z-2095-2025 Class I | Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXCertain Spectrum infusion pumps may have an incorrect version of software. | Baxter Healthcare Corporation | 06/20/2025Open, Classified |
| Z-2102-2025 Class I | i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is…Potential for faulty devices as a result of depleted batteries. | Intersurgical Inc | 06/17/2025Open, Classified |
| Z-2161-2025 Class I | SafeStar 60A Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2160-2025 Class I | HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2159-2025 Class I | SafeStar 55 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2158-2025 Class I | SafeStar 90 Plus Filter. Bidirectionally breathing system filter.Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. | Draeger, Inc. | 06/16/2025Open, Classified |
| Z-2328-2025 Class I | Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton…A mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect… | Hamilton Medical AG | 06/03/2025Open, Classified |
| Z-2047-2025 Class I | Bravo CF capsule delivery device, designed to place and attach a pH monitoring capsule…It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its… | Given Imaging Ltd. | 06/03/2025Open, Classified |
| Z-2032-2025 Class I | Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits…The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on… | Baxter Healthcare Corporation | 05/30/2025Open, Classified |
| Z-2031-2025 Class I | Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile…The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on… | Baxter Healthcare Corporation | 05/30/2025Open, Classified |
| Z-2015-2025 Class I | Servo-u MR Ventilator System. Model Number: 6888800.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due… | Maquet Critical Care AB | 05/30/2025Open, Classified |
| Z-2014-2025 Class I | Servo-n Ventilator System. Model Number: 6694800.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due… | Maquet Critical Care AB | 05/30/2025Open, Classified |
| Z-2013-2025 Class I | Servo-u Ventilator System. Model Number: 6688600.Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due… | Maquet Critical Care AB | 05/30/2025Open, Classified |
| Z-1961-2025 Class I | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and filtered line…Lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/23/2025Open, Classified |
| Z-1960-2025 Class I | Extended Tip Applicator 8CM, Box of 1.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1959-2025 Class I | Extended Tip Applicator, 15 CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1958-2025 Class I | Extended Tip Applicator, 8CM, Box of 5.Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance. | Integra LifeSciences Corp. (NeuroSciences) | 05/22/2025Open, Classified |
| Z-1915-2025 Class I | Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR…Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result… | Covidien | 05/21/2025Open, Classified |
| Z-1904-2025 Class I | Broselow Pediatric Emergency Rainbow Tape (distribution by AirLife); REF 7700REA AirLife…The impacted tape was manufactured with incorrect information on the tape. Incorrect values are printed in… | SunMed Holdings, LLC | 05/15/2025Open, Classified |
| Z-1902-2025 Class I | Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and…Cook Medical identified that catheters supplied in the affected device lots may experience tip separation. | Cook Incorporated | 05/15/2025Open, Classified |
| Z-2085-2025 Class I | Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2084-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2083-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2082-2025 Class I | Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number:…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2081-2025 Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-2080-2025 Class I | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula…due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula… | Edwards Lifesciences, LLC | 05/14/2025Open, Classified |
| Z-1946-2025 Class I | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | Dexcom, Inc. | 05/12/2025Open, Classified |
| Z-1945-2025 Class I | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | Dexcom, Inc. | 05/12/2025Open, Classified |
| Z-1944-2025 Class I | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | Dexcom, Inc. | 05/12/2025Open, Classified |
| Z-1943-2025 Class I | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001…Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit… | Dexcom, Inc. | 05/12/2025Open, Classified |
| Z-1869-2025 Class I | IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing…Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be… | Fresenius Kabi USA, LLC | 05/12/2025Open, Classified |
| Z-2037-2025 Class I | BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of…This device does not indicate for use in patients with respiratory failure. | Philips Respironics, Inc. | 05/09/2025Open, Classified |
| Z-2036-2025 Class I | BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and…This device does not indicate for use in patients with respiratory failure. | Philips Respironics, Inc. | 05/09/2025Open, Classified |
| Z-2035-2025 Class I | BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for…This device does not indicate for use in patients with respiratory failure. | Philips Respironics, Inc. | 05/09/2025Open, Classified |
| Z-1868-2025 Class I | Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1867-2025 Class I | Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1866-2025 Class I | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1865-2025 Class I | Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids…Unreleased software versions were installed on distributed devices without verification or validation. | Zyno Medical LLC | 05/07/2025Open, Classified |
| Z-1814-2025 Class I | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7…Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead… | SunMed Holdings, LLC | 05/01/2025Open, Classified |
| Z-1767-2025 Class I | Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSThere is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the… | Baxter Healthcare Corporation | 04/24/2025Open, Classified |
| Z-1811-2025 Class I | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU…Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2025Open, Classified |
| Z-1810-2025 Class I | Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349CAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2025Open, Classified |
| Z-1809-2025 Class I | Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU…Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on… | MEDLINE INDUSTRIES, LP - Northfield | 04/22/2025Open, Classified |
| Z-1746-2025 Class I | Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product…Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures… | Ethicon Endo-Surgery Inc | 04/22/2025Open, Classified |
| Z-1759-2025 Class I | Bard Single Intragastric Linton Balloon Tube, REF: 0092740Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | C.R. Bard Inc | 04/17/2025Open, Classified |
| Z-1758-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | C.R. Bard Inc | 04/17/2025Open, Classified |
| Z-1757-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | C.R. Bard Inc | 04/17/2025Open, Classified |
| Z-1756-2025 Class I | Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | C.R. Bard Inc | 04/17/2025Open, Classified |
| Z-1755-2025 Class I | Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm…Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove… | C.R. Bard Inc | 04/17/2025Open, Classified |
| Z-1760-2025 Class I | Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate…Centerline Biomedical has determined that the coating on the guidewires for lot 2404-2005 may delaminate… | Centerline Biomedical Inc | 04/11/2025Open, Classified |
| Z-1730-2025 Class I | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X.…Potential for the presence of visible foreign matter. | Nipro Renal Soultions USA, Corporation | 04/11/2025Open, Classified |
| Z-1727-2025 Class I | iGo2 DC Car Adapter to be used with iGo2 Portable Oxygen Concentrator Systems. Power…Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. | Medical Depot Inc. | 04/11/2025Open, Classified |
| Z-1717-2025 Class I | CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial…Inadequate weld that can potentially cause the product to disassemble. | Integra LifeSciences Corp. (NeuroSciences) | 04/11/2025Open, Classified |
| Z-1716-2025 Class I | CODMAN Disposable Perforator, 14mm. Cranial perforator.Inadequate weld that can potentially cause the product to disassemble. | Integra LifeSciences Corp. (NeuroSciences) | 04/11/2025Open, Classified |
| Z-2483-2025 Class I | 3M Ranger Blood/Fluid Warming High Flow Set Catalog Numbers 24355, 24370Field action to clarify the flow rates and inlet fluid temperatures, along with location of the outlet… | 3M Company | 04/10/2025Open, Classified |
| Z-1698-2025 Class I | Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog…Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any… | Vyaire Medical | 04/10/2025Open, Classified |