Covidien LLC
Medical device manufacturer in Mansfield, MA.
223510(k) clearances
2PMA approvals
571recalls
Device types
- GEI Electrosurgical, Cutting & Coagulation &… 40
- GDW Staple, Implantable 27
- GCJ Laparoscope, General & Plastic Surgery 13
- DQA Oximeter 10
- JOW Sleeve, Limb, Compressible 8
- JOH Tube Tracheostomy And Tube Cuff 7
- BTR Tube, Tracheal (W/Wo Connector) 6
- NEY System, Ablation, Microwave And Accessories 5
- GAG Stapler, Surgical 5
- PNR Enteral Syringes With Enteral Specific… 4
- GXY Electrode, Cutaneous 4
- KNT Tubes, Gastrointestinal (And Accessories) 4
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 4
- CBK Ventilator, Continuous, Facility Use 4
- LFL Instrument, Ultrasonic Surgical 4
- MWI Monitor, Physiological, Patient (Without… 4
- FZP Clip, Implantable 4
- LLZ System, Image Processing, Radiological 3
- MSD Catheter, Hemodialysis, Implanted 3
- LZH Pump, Infusion, Enteral 3
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K260907 | BIS Advance pEEG ModuleOLW · Traditional | 08/13/2026SE |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0…GAG · Traditional | 07/01/2026SE |
| K253984 | Instrument Exit Point on Touch Surgery AideSFE · Traditional | 06/04/2026SE |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN)CCK · Traditional | 05/01/2026SE |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with…JOH · Traditional | 12/29/2025SE |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043…BZT · Traditional | 12/29/2025SE |
| K250725 | Hugo RAS SystemSCV · Traditional | 12/03/2025SE |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal…BTR · Traditional | 10/06/2025SE |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley…BTR · Traditional | 09/25/2025SE |
| K241486 | Sofsilk Coated Braided Silk SutureGAP · Traditional | 12/03/2024SE |
| K240077 | Mon-a-Therm General Purpose Temperature Probe 400TM (90050, 90044)FLL · Traditional | 08/20/2024SE |
| K241085 | Valleylab FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN)GEI · Traditional | 07/12/2024SE |
| K240572 | Valleylab SM Smoke Management Pencil with Edge Blade Electrode, 10 (3m) (VSMP10)…GEI · Traditional | 07/01/2024SE |
| K233341 | Shiley Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440…BTR · Traditional | 05/20/2024SE |
| K230693 | BIS Advance Monitoring SystemOLW · Traditional | 02/26/2024SE |
| K231934 | GIA Stapler with Tri-Staple TechnologyGAG · Traditional | 10/27/2023SE |
| K231240 | MaxTack Motorized Fixation DeviceOCW · Traditional | 09/08/2023SE |
| K223130 | Shiley Pediatric Oral/Nasal Endotracheal Tube with TaperGuard Cuff, Non DEHP (86125…BTR · Traditional | 08/30/2023SE |
| K232126 | EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler…GAG · Special | 08/16/2023SE |
| K231491 | TA Stapler and Loading Unit with DST Series TechnologyGAG · Traditional | 08/16/2023SE |
| K231861 | EndoflipTM 300 SystemFFX · Special | 07/21/2023SE |
| K223705 | EndoflipTM 300FFX · Traditional | 04/14/2023SE |
| K221629 | Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)GAG · Traditional | 02/22/2023SE |
| K223158 | LigaSure XP Maryland Jaw Sealer/DividerGEI · Traditional | 01/23/2023SE |
| K221771 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | 11/30/2022SE |
| K222641 | Signia Small Diameter Reloads Including Regular (Round) Tip VersionGDW · Traditional | 11/29/2022SE |
| K221003 | Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture…GDW · Traditional | 09/30/2022SE |
| K220540 | ProGrip Self-Gripping Polypropylene MeshFTL · Special | 09/22/2022SE |
| K213911 | Microstream CO2 NanoPodCCK · Traditional | 07/29/2022SE |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation…GCJ · Traditional | 06/27/2022SE |
| K212555 | Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult…DQA · Traditional | 05/06/2022SE |
| K221013 | GIA Auto Suture Stapler with DST Series TechnologyGDW · Special | 05/05/2022SE |
| K221006 | GIA Stapler with Tri-Staple TechnologyGDW · Special | 04/29/2022SE |
| K221005 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Special | 04/29/2022SE |
| K213518 | CARESCAPE CO2 Microstream parameterCCK · Traditional | 04/12/2022SE |
| K203150 | Cool-tip RF Ablation System E SeriesGEI · Traditional | 02/25/2022SE |
| K213602 | Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter…FJS · Traditional | 01/14/2022SE |
| K211561 | INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional…MUD · Traditional | 12/05/2021SE |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceLFL · Traditional | 11/15/2021SE |
| K203762 | Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric…CCK · Traditional | 09/17/2021SE |
| K210338 | Edge Insulated Blade ElectrodeGEI · Traditional | 04/15/2021SE |
| K202917 | LigaSure Exact Dissector, Nano-coatedGEI · Traditional | 03/23/2021SE |
| K202507 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | 01/21/2021SE |
| K202874 | Puritan Bennett Cuff Pressure ManagerBSK · Traditional | 01/09/2021SE |
| K203303 | Emprint SX Ablation Platform with Thermosphere TechnologyNEY · Special | 12/17/2020SE |
| K202701 | GIA Stapler with Tri-Staple TechnologyGDW · Special | 12/07/2020SE |
| K193056 | Puritan Bennett 980 Series Ventilator SystemCBK · Traditional | 11/20/2020SE |
| K202864 | Tri-Staple 2.0 ReloadsGDW · Special | 10/28/2020SE |
| K201805 | VersaOne Reusable Positioning Trocar SystemGCJ · Traditional | 08/26/2020SE |
| K200796 | Emprint Ablation System with Thermosphere TechnologyNEY · Traditional | 08/26/2020SE |
| K201179 | GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor CableDQA · Traditional | 07/20/2020SE |
| K201672 | Signia Stapler (with new software)GDW · Special | 07/17/2020SE |
| K200427 | Sonicision Cordless Ultrasonic DissectorLFL · Special | 07/10/2020SE |
| K193077 | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard CuffJOH · Traditional | 06/01/2020SE |
| K200146 | HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorGEI · Traditional | 05/07/2020SE |
| K192720 | GIA Stapler with Tri-Staple TechnologyGDW · Traditional | 03/13/2020SE |
| K193356 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerGEI · Traditional | 03/02/2020SE |
| K193232 | Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…NEY · Special | 02/13/2020SE |
| K192330 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | 01/23/2020SE |
| K192302 | Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute…MPB · Traditional | 01/17/2020SEKD |
| K192038 | Emprint Visualization ApplicationLLZ · Traditional | 12/02/2019SE |
| K191070 | Signia Small Diameter ReloadsGDW · Traditional | 09/04/2019SE |
| K191394 | ILLUMISITE PlatformJAK · Traditional | 08/07/2019SE |
| K191601 | Valleylab FT10 Electrosurgical PlatformGEI · Special | 07/12/2019SE |
| K182861 | Shiley Neonatal/Pediatric Tracheostomy TubeJOH · Traditional | 03/22/2019SE |
| K182475 | Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads…GDW · Traditional | 03/14/2019SE |
| K182868 | INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorMUD · Traditional | 01/08/2019SE |
| K182772 | Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation…GEI · Traditional | 11/19/2018SE |
| K182451 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerGEI · Traditional | 11/06/2018SE |
| K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-PortKNT · Traditional | 10/23/2018SE |
| K180496 | TruClear Elite HysteroscopeHIH · Traditional | 08/29/2018SE |
| K181020 | Cytosponge Cell Collection DeviceEOX · Traditional | 08/16/2018SE |
| K180485 | Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis…FJS · Traditional | 07/27/2018SESK |
| K180915 | Sonicision Reusable Sterilization TrayKCT · Traditional | 07/17/2018SE |
| K181085 | LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coatedGEI · Traditional | 06/21/2018SE |
| K181389 | Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy PlatformGEI · Special | 06/19/2018SE |
| K180037 | Beacon EUS Access SystemFCG · Traditional | 04/26/2018SE |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…LFL · Traditional | 03/26/2018SE |
| K180192 | Emprint Ablation Visualization ApplicationLLZ · Traditional | 03/21/2018SE |
| K173281 | LigaSure Exact Dissector, Nano-coatedGEI · Traditional | 03/02/2018SE |
| K173270 | Tri-Staple 2.0 Reinforced ReloadGDW · Traditional | 02/20/2018SE |
| K172361 | EEA Circular Stapler with Tri-Staple TechnologyGDW · Traditional | 02/16/2018SE |
| K173244 | superDimension Navigation System V7.2JAK · Traditional | 02/08/2018SE |
| K173559 | Barrx SB RFA Endoscopic CatheterKNS · Special | 01/18/2018SE |
| K172482 | The Nellcor pulse oximetry monitor interface cableDQA · Traditional | 12/15/2017SE |
| K172757 | Valleylab FX8 Electrosurgical PlatformGEI · Traditional | 11/02/2017SE |
| K162738 | Puritan Bennett 980 Ventilator SystemCBK · Traditional | 10/27/2017SE |
| K171066 | BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/DividerGEI · Traditional | 06/08/2017SE |
| K170869 | LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coatedGEI · Special | 04/21/2017SE |
| K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaEOQ · Traditional | 04/21/2017SE |
| K163654 | VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless…GCJ · Traditional | 03/08/2017SE |
| K170348 | Signia Four-Bay Smart Charger (to be used with Signia Stapler)GDW · Special | 03/02/2017SE |
| K170170 | Valleylab FT10 Electrosurgical PlatformGEI · Special | 02/16/2017SE |
| K162802 | Barrx Anorectal RFA WandGEI · Traditional | 01/24/2017SE |
| K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort…JOW · Special | 01/19/2017SE |
| K163055 | Reprocessed Kendall SCD Express Foot CuffJOW · Traditional | 12/23/2016SE |
| K163105 | Emprint Ablation SystemNEY · Special | 12/06/2016SE |
| K163098 | Tri-Staple 2.0 Intelligent CartridgeGDW · Special | 12/05/2016SE |
| K163102 | ReliaCatch Specimen Retrieval Bag 10mm; ReliaCatch Specimen Retrieval Bag 12mmGCJ · Special | 11/30/2016SE |
| K162941 | Ligasure Blunt Tip, Sealer/Divider, Nano-coatedGEI · Special | 11/14/2016SE |
| K160718 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformMWI · Traditional | 11/14/2016SE |
| K162584 | VersaOne Bladeless TrocarGCJ · Special | 10/18/2016SE |
| K161804 | LigaSure Retractable L-Hook Laparoscopic Sealer/DividerGEI · Traditional | 09/16/2016SE |
| K162047 | LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coatedGEI · Special | 09/15/2016SE |
| K161347 | Signia sterilization trayKCT · Traditional | 09/07/2016SE |
| K161963 | Monoject Enteral Syringe with ENFit ConnectorPNR · Traditional | 09/01/2016SE |
| K161105 | Reprocessed Compression GarmentsJOW · Traditional | 08/18/2016SE |
| K160331 | LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable…GEI · Traditional | 08/12/2016SE |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…LZH · Traditional | 07/06/2016SE |
| K161045 | MonojectPNR · Traditional | 06/17/2016SE |
| K160539 | BiZact Open Sealer/DividerGEI · Traditional | 06/15/2016SE |
| K160290 | Valleylab REM Polyhesive Infant Patient Return ElectrodeGEI · Traditional | 05/19/2016SE |
| K160419 | Monoject Enteral Feeding Syringe with ENFit ConnectorPNR · Traditional | 05/12/2016SE |
| K160654 | GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)KNT · Special | 05/04/2016SE |
| K160176 | Signia StaplerGDW · Traditional | 04/26/2016SE |
| K152794 | Cytosponge Cell Collection DeviceEOX · Traditional | 04/12/2016SE |
| K160360 | Barrx FLEX RFA Energy GeneratorGEI · Traditional | 04/05/2016SE |
| K151252 | Puritan Bennett 840 Series Ventilator SystemCBK · Traditional | 03/29/2016SE |
| K153371 | Sonicision Cordless Ultrasonic Dissection DeviceLFL · Traditional | 03/28/2016SE |
| K160230 | VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mmGCJ · Special | 03/01/2016SE |
| K152149 | VersaOne Bladed Trocar 5mmGCJ · Special | 01/22/2016SE |
| K152586 | Beacon Fine Needle Fiducial SystemNEU · Traditional | 12/30/2015SE |
| K151381 | Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy EyeBTR · Traditional | 12/11/2015SE |
| K151376 | superDimension Navigation SystemJAK · Traditional | 11/05/2015SE |
| K150835 | LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol GripGEI · Traditional | 10/15/2015SE |
| K152565 | Auto Suture Locking TrocarGCJ · Special | 10/09/2015SE |
| K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional PortPIF · Traditional | 10/08/2015SE |
| K143644 | Premium Surgiclip¿; Endo Clip¿; AcuClip¿FZP · Traditional | 09/14/2015SE |
| K151649 | Valleylab FT10 Electrosurgical PlatformGEI · Traditional | 09/10/2015SE |
| K152286 | LigaSure Curved, Small Jaw, Open Sealer/DividerGEI · Special | 09/08/2015SE |
| K150735 | Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical…GEI · Traditional | 08/04/2015SE |
| K150251 | Barrx Anorectal RFA WandGEI · Traditional | 07/28/2015SE |
| K151659 | ReliaTack Articulating Reloadable Fixation Device with Deep Purchase Reloadable TacksGDW · Special | 07/17/2015SE |
| K150844 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Reusable Inner Cannula, Shiley Adult…JOH · Traditional | 07/14/2015SE |
| K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric…PIF · Traditional | 07/13/2015SE |
| K151548 | VersaOne Bladed Trocar, VersaOne Bladeless TrocarGCJ · Special | 07/02/2015SE |
| K151356 | Spacemaker Pro Access and Dissector SystemGCJ · Special | 06/18/2015SE |
| K142934 | CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access…EOQ · Traditional | 06/17/2015SE |
| K151163 | Signia Loading Unit, Tri-Staple 2.0 CartridgeGDW · Special | 05/29/2015SE |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsLZH · Traditional | 05/29/2015SE |
| K142839 | GenCut Core Biopsy SystemEOQ · Traditional | 04/29/2015SE |
| K143506 | Bis Standard SENSOR,1-CHANNEL (3 Electrodes); Bis Pedi SENSOR,1-CHANNEL,3 Electrodes…GXY · Traditional | 04/16/2015SE |
| K143654 | Valleylab LS10 GeneratorGEI · Traditional | 04/03/2015SE |
| K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore ConnectorsPIF · Traditional | 04/02/2015SE |
| K142865 | Nellcor Bedside SpO2 Patient Monitoring SystemDQA · Traditional | 03/26/2015SE |
| K143598 | Lapro-Clip Auto Suture Reusable Long Clip ApplierFZP · Special | 03/12/2015SE |
| K141518 | Nellcor Bedside Respiratory Patient Monitoring SystemDQA · Traditional | 03/05/2015SE |
| K143088 | GastriSail Gastric Positioning SystemKNT · Traditional | 02/25/2015SE |
| K142296 | Shiley Adult Flexible Tracheostomy Tube Cuffless, Disposable Inner Cannula; Shiley Adult…JOH · Traditional | 02/24/2015SE |
| K142128 | Kangaroo Enteral Feeding Syringes with Enfit ConnectorPNR · Traditional | 02/23/2015SE |
| K142298 | Shiley Neonatal, Pediatric & Pediatric Long Tracheostomy Tubes with TaperGuard CuffJOH · Traditional | 02/13/2015SE |
| K142656 | Surgical Gut SutureGAL · Special | 01/29/2015SE |
| K142929 | Ligasure Blunt Tip Sealer/DividerGEI · Traditional | 01/27/2015SE |
| K142335 | RapidVac Smoke Evacuator SystemFYD · Traditional | 01/14/2015SE |
| K141479 | Kangaroo Enteral Feeding Set with Enfit ConnectorsLZH · Traditional | 12/23/2014SE |
| K143161 | Force FX-8(S), Force FX-8C(S), Force FX-8CA(S)GEI · Special | 12/19/2014SE |
| K142547 | Bluntport Blunt Trocar with Threaded Anchor 5mm-12mmGCJ · Special | 12/09/2014SE |
| K143091 | Surgisleeve Wound ProtectorGCJ · Special | 11/26/2014SE |
| K142695 | Cytosponge Cell Collection DeviceEOX · Traditional | 11/26/2014SE |
| K142869 | Premium Surgiclip IIIFZP · Special | 10/30/2014SE |
| K142654 | Fortrex 0.035 OTW PTA Balloon CatheterLIT · Traditional | 10/28/2014SE |
| K141801 | Hawkone Directional Atherectomy SystemMCW · Traditional | 10/16/2014SE |
| K142198 | BNX Fine Needle Aspiration SystemNEU · Traditional | 10/08/2014SE |
| K141542 | Nellcor Portable SPO2 Patient Monitoring System ( Npspms )DQA · Traditional | 10/02/2014SE |
| K142364 | Barrx RFA Self Sizing Balloon CatheterGEI · Special | 10/01/2014SE |
| K142048 | Emprint Procedure Planning ApplicationLLZ · Traditional | 09/17/2014SE |
| K141153 | Ligasure; Curved Small Jaw Sealer/Divider, 5MM Blunt Tip Sealer/Divider, Maryland Jaw…GEI · Traditional | 08/14/2014SE |
| K141858 | Closurerfg Radiofrequency GeneratorGEI · Special | 08/05/2014SE |
| K140813 | Reprocessed Kendall SCD Express Compression SleevesJOW · Traditional | 07/15/2014SE |
| K133821 | Emprint Ablation SystemNEY · Traditional | 04/28/2014SE |
| K140339 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformMWI · Traditional | 04/10/2014SE |
| K140609 | Reliatack Articulating Reloadable Fixation Device with Standard Purchase Absorble TacksGDW · Special | 04/09/2014SE |
| K123555 | Kangaroo Feeding Tubes with Iris TechnologyKNT · Traditional | 04/09/2014SE |
| K140064 | Surgisleeve Wound ProtectorKKX · Traditional | 03/12/2014SE |
| K131252 | Puritan Bennett 980 Series Ventilator SystemCBK · Traditional | 02/24/2014SE |
| K130320 | Bedside Respiratory Patient Monitoring System, Bedside Respiratory Patient Monitoring…DQA · Traditional | 02/04/2014SE |
| K133938 | Endo Gia Reinforced Reload with Tri-Staple TechnologyGDW · Special | 01/22/2014SE |
| K133762 | Endo Gia(Tm) Extra Long AdapterGDW · Special | 01/08/2014SE |
| K132604 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformMWI · Special | 12/04/2013SE |
| K130357 | Superdimension Triple-Needle Cytology BrushBTG · Traditional | 11/06/2013SE |
| K132567 | Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted…LJS · Special | 11/05/2013SE |
| K130904 | TRELLIS-8 Peripheral Infusion SystemQEY · Traditional | 10/25/2013SE |
| K132493 | Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Special | 10/23/2013SE |
| K131614 | Reprocessed Closurefast Radiofrequency Catheter 60CM, Reprocessed Closurefast…NUJ · Traditional | 08/29/2013SE |
| K132360 | Kendall SCD 700 Sequential Compression ControllerJOW · Special | 08/27/2013SE |
| K131361 | Warmtouch Surgical Access Blanket, Warmtouch Torso BlanketDWJ · Traditional | 07/29/2013SE |
| K130623 | Barrx Channel Rfa Endoscopic CatheterKNS · Traditional | 07/26/2013SE |
| K130796 | Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformMWI · Traditional | 05/09/2013SE |
| K123083 | Covidien Warmtouch Convective Warming UnitDWJ · Traditional | 04/17/2013SE |
| K130782 | Accumesh Deployment SystemORQ · Special | 04/05/2013SE |
| K130744 | Ligasure 5MM Blunt Tip Laparoscopic Sealer/DividerGEI · Special | 04/05/2013SE |
| K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter…MSD · Traditional | 01/31/2013SE |
| K123109 | Absorbatack 5MM Single Use Absorbable Fixation DeviceGDW · Special | 10/23/2012SE |
| K123066 | Accumesh Deployment SystemORQ · Special | 10/16/2012SE |
| K122531 | Shiley Neonatal Tracheostomy Tube Cuffless, Shiley Pediatric Tracheostomy Tube Cuffless…JOH · Special | 10/09/2012SE |
| K121806 | Beside Respiratory Patient Monitoring System Beside Resiratory Patient Monitoring System…DQA · Abbreviated | 09/28/2012SE |
| K120773 | Nellcor Bedside SPO2 Patient Monitoring SystemDQA · Traditional | 07/10/2012SE |
| K120944 | Kendall SCD 700 Sequential Compression ControllerJOW · Traditional | 05/31/2012SE |
| K120605 | Permacol Surgical ImplantFTM · Traditional | 05/18/2012SE |
| K121194 | Endo Clip III 5MM Clip ApplierFZP · Special | 05/03/2012SE |
| K121139 | Accumesh Deployment SystemORQ · Special | 05/02/2012SE |
| K120863 | Wholey Guide Wire SystemDQX · Traditional | 04/19/2012SE |
| K112536 | Sonicision Sterilization TrayKCT · Abbreviated | 04/19/2012SE |
| K120674 | Mahurkar Elite Acute Dual Lumen Catheter, Elite Acute Triple Lumen CatheterMPB · Special | 04/04/2012SESK |
| K111933 | Covidien Nellcor Respiration Rate Software Application, Version 1.0BZQ · Traditional | 03/15/2012SE |
| K112477 | Palindrome H, Si, Hsi Chronic CatheterNYU · Special | 09/28/2011SESK |
| K111887 | Closurefast Radiofrequency CatheterGEI · Special | 09/09/2011SE |
| K111817 | Palindrome RT Chronic CatheterMSD · Special | 08/30/2011SESK |
| K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…MSD · Special | 08/04/2011SESK |
| K103052 | V-Loc(Tm) Nonabsorbable Wound Closure DeviceGAT · Traditional | 11/10/2010SE |
| K102737 | Kendall SCD 700 Sequential Compression ControllerJOW · Special | 10/19/2010SE |
| K102291 | Covidien Endo Gia Radial Reload with Tri-Staple TechnologyGDW · Traditional | 09/15/2010SE |
| K100418 | Superior Starburst Reusable Self-Adhering Tens/Nmes/Fes Stimulating ElectrodeGXY · Traditional | 09/03/2010SE |
| K100306 | Kendall SCD Sequential Compression Comfort SleevesJOW · Traditional | 05/04/2010SE |
| K091762 | Dura-Stick Self-Adhesive Electrodes with AloeGXY · Traditional | 12/22/2009SE |
| K091223 | Valleylab Suction Coagulator, Model E3305GEI · Traditional | 09/11/2009SE |
| K090470 | Autosuture Protack; Tacker System; Absorbatack Fixation DevicesOCW · Traditional | 05/14/2009SE |
| K083350 | Tens/Nmes/Fes Stimulating ElectrodeGXY · Traditional | 04/21/2009SE |
| K090352 | Taperguard Endotracheal Tubes, Taperguard Evac Endotracheal TubesBTR · Special | 04/03/2009SE |
| K083325 | N-600X with SPD, Oximax N-600XDQA · Traditional | 03/09/2009SE |
| K082322 | Air Assisted Sprayer, Models: AIRSPRAYUS01 and AirsprayusGCJ · Traditional | 11/14/2008SE |
| K082454 | Micromyst Applicator, Model 20-5000FMF · Traditional | 11/07/2008SE |
| K072814 | Convenience Kit for Single-Incision Laparoscopic Surgery and Other Advanced Laparoscopic…KDD · Traditional | 04/16/2008SE |
PMA approvals
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2922-2026 Class II | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GXProduct may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2921-2026 Class II | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2920-2026 Class II | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2919-2026 Class II | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4 BOX BY…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2918-2026 Class II | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336 VLOC 90 0 VL 22…Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in… | 06/24/2026Open, Classified |
| Z-2950-2026 Class II | EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307…Due to products are incorrectly flagged as expired due to the system's 24-hour usage limit, rendering the… | 05/13/2026Open, Classified |
| Z-2653-2026 Class II | Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060…Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as… | 04/23/2026Open, Classified |
| Z-2273-2026 Class II | Covidien Mon-a-Therm general purpose temperature probe size: 9 Fr REF: 90050Temperature probe devices lack FDA clearance. | 04/23/2026Open, Classified |
| Z-2272-2026 Class II | Covidien Mon-a-Therm General Purpose Temperature Probe REF: 90044Temperature probe devices lack FDA clearance. | 04/23/2026Open, Classified |
| Z-2271-2026 Class II | Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM REF: 90042Temperature probe devices lack FDA clearance. | 04/23/2026Open, Classified |
| Z-2281-2026 Class II | Covidien EndoStitch" Polysorb Single Use Loading Unit; Product numbers: 170053 and 170071;The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and… | 04/15/2026Open, Classified |
| Z-2261-2026 Class II | COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code:…Due to customer complaint regarding incorrect display box labeling. | 04/15/2026Open, Classified |
| Z-1557-2026 Class II | HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product…Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not… | 01/30/2026Open, Classified |
| Z-0486-2026 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); BOX…A manufacturing issue could lead to a malformed cover tube press which can lead to internal components'… | 09/25/2025Open, Classified |
| Z-0485-2026 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload (45mm Vascular/Thin); CFN:…A manufacturing issue could lead to a malformed cover tube press which can lead to internal components'… | 09/25/2025Open, Classified |
| Z-2151-2025 Class II | Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941…Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of… | 06/23/2025Open, 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… | 05/21/2025Open, Classified |
| Z-1390-2025 Class I | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula…Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula… | 02/26/2025Open, Classified |
| Z-0257-2025 Class II | Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US)…Specific lots of the Chameleon PTA Balloon Catheter failed to meet in-house balloon pressure testing. | 09/19/2024Open, Classified |
| Z-2717-2024 Class II | Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnlyIFU update to address device's battery handling information. | 07/09/2024Open, Classified |
| Z-2637-2024 Class I | McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result… | 07/09/2024Open, Classified |
| Z-2636-2024 Class I | McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx OnlyBattery management system within Laryngoscope devices may deplete below the deign threshold which may result… | 07/09/2024Open, Classified |
| Z-2446-2024 Class I | Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560…Any single affected ventilator should only be used for the 10- year labelled service life, but if longer… | 06/24/2024Open, Classified |
| Z-2038-2024 Class II | EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyDue to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate… | 04/25/2024Open, Classified |
| Z-1891-2024 Class II | Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal…Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may… | 04/15/2024Open, Classified |
| Z-1635-2024 Class II | Palindrome Precision H Chronic Catheter Kit 14.5 Fr/Ch (4.8mm) x 23 cm (Symmetrical Tip…Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the… | 03/15/2024Open, Classified |
| Z-1634-2024 Class II | Palindrome Precision HSI Chronic Catheter Sport Pack 14.5 Fr/Ch (4.8mm) x 19 cm…Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the… | 03/15/2024Open, Classified |
| Z-1471-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1470-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1469-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1468-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1467-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1466-2024 Class II | Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNLThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1465-2024 Class II | Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SBThe potential for trocar seal disengagement when using mesh products incorrectly with the device. | 02/28/2024Open, Classified |
| Z-1330-2024 Class II | Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable… | 02/21/2024Open, Classified |
| Z-1458-2024 Class II | Covidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially… | 02/14/2024Open, Classified |
| Z-1457-2024 Class II | Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTUnder certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially… | 02/14/2024Open, Classified |
| Z-1697-2024 Class II | Sofsilk Braided Silk sutures, Product Number S-2782K. Nonabsorbable, sterile…One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles.… | 01/25/2024Open, Classified |
| Z-1732-2024 Class II | Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSCmanufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | 01/09/2024Open, Classified |
| Z-1731-2024 Class II | Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RICmanufacturing defects to sensor cable connectors may result in error codes or non-functioning channel | 01/09/2024Open, Classified |
| Z-0845-2024 Class II | Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0…Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma… | 12/21/2023Open, Classified |
| Z-0844-2024 Class II | Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41…Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma… | 12/21/2023Open, Classified |
| Z-0986-2024 Class II | AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for…Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially… | 11/16/2023Open, Classified |
| Z-0631-2024 Class II | Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN…Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in… | 11/16/2023Open, Classified |
| Z-0144-2024 Class I | Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000Defective video laryngoscopes that did not pass quality tests established for the product, that were… | 09/28/2023Open, Classified |
| Z-2651-2023 Class II | Puritan Bennett Cuff Pressure Manager, REF: 180-03Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external… | 08/22/2023Open, Classified |
| Z-2632-2023 Class II | Palindrome Chronic Catheter Kit Symmetrical Tip14.5 Fr/Ch(4.8mm)x23cmSome catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length… | 08/22/2023Open, Classified |
| Z-0169-2024 Class II | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx OnlyLaryngoscope blades may contain an ineffective application of anti-fog agent which may result in… | 08/10/2023Open, Classified |
| Z-0168-2024 Class II | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx OnlyLaryngoscope blades may contain an ineffective application of anti-fog agent which may result in… | 08/10/2023Open, Classified |
| Z-2391-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2390-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Curved Extensions, Kit REF:…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2389-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2388-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF:…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2387-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2386-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 16 cm, Curved Extensions, Kit" REF:…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2385-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2384-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit" REF:…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2383-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2382-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2381-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2380-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, Kit…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2379-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2378-2023 Class I | MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2377-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2376-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2375-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2374-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2373-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2372-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2371-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2370-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2369-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2368-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2367-2023 Class I | MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved…Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion… | 06/28/2023Open, Classified |
| Z-2282-2023 Class II | Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell…Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of… | 06/02/2023Open, Classified |
| Z-2008-2023 Class II | Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CSSingle ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a… | 05/22/2023Open, Classified |
| Z-1357-2023 Class I | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable…A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube… | 03/24/2023Open, Classified |
| Z-1465-2023 Class II | VersaOne Reusable Positioning Cannula 12mm Standard, Model Number RC12STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | 03/22/2023Open, Classified |
| Z-1464-2023 Class II | VersaOne Reusable Positioning Cannula 11mm Standard, Model Number RC11STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | 03/22/2023Open, Classified |
| Z-1463-2023 Class II | VersaOne Reusable Positioning Cannula 8 mm Standard, Model Number RC8STSThere is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the… | 03/22/2023Open, Classified |
| Z-1390-2023 Class II | Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | 03/01/2023Open, Classified |
| Z-1389-2023 Class II | Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | 03/01/2023Open, Classified |
| Z-1388-2023 Class II | Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | 03/01/2023Open, Classified |
| Z-1387-2023 Class II | Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5…Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may… | 03/01/2023Open, Classified |
| Z-1318-2023 Class II | COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley…Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. | 02/10/2023Open, Classified |
| Z-1228-2023 Class II | Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXTAffected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to… | 01/25/2023Open, Classified |
| Z-1183-2023 Class II | Parietex Composite Mesh Polyester with Absorbable Collagen Film, Horseshoe- Shaped, 9 x…Collagen film was placed on the opposite side of the mesh may cause delay to treatment/therapy, adhesions… | 01/11/2023Open, Classified |
| Z-0877-2023 Class I | MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx…There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the… | 12/07/2022Open, Classified |
| Z-1182-2023 Class II | Custom Suture Pack Product Description: US1638 CUSTOM SUTURE PACK US1756 CUSTOM SUTURE…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1181-2023 Class II | Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1180-2023 Class II | Surgipro II Monofilament Polypropylene Sutures Product Description Model Number VP-421X…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1179-2023 Class II | Surgipro Monofilament Polypropylene Sutures Product Description CP-535 SURGIPRO* 1 BLU…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1178-2023 Class II | Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1177-2023 Class II | Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1176-2023 Class II | Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1175-2023 Class II | Novafil Monofilament Polybutester Suture Product Description: 8886 4002-41 NOVAFIL 3-0…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1174-2023 Class II | Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1173-2023 Class II | Monofilament Nylon Suture (McKesson Branded) and Coated Braided Silk Suture (McKesson…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-1172-2023 Class II | Dermalon Monofilament Nylon Suture: (1) 88861741-11 DERMALON* 6-0 BLU 45CM C1 (2)…Sterile Barrier Breach of Breather Pouch may cause infection or vision loss for ophthalmic procedures in… | 12/02/2022Open, Classified |
| Z-0955-2023 Class II | COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation…The product is labeled with the incorrect expiration date. | 11/23/2022Open, Classified |
| Z-0201-2023 Class II | Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L…Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s)… | 09/28/2022Open, Classified |
| Z-0200-2023 Class II | Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L…Medtronic has received 210 reports of needles breaking during endoscopic suturing. The potential harm(s)… | 09/28/2022Open, Classified |
| Z-1775-2022 Class II | Puritan Bennett 560 Ventilator, PB560, CFN 4096600Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due… | 08/19/2022Open, Classified |
| Z-1320-2022 Class I | Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1319-2022 Class I | Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1318-2022 Class I | Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1317-2022 Class I | Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1316-2022 Class I | Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1315-2022 Class I | Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1314-2022 Class I | Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1313-2022 Class I | Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1312-2022 Class I | Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access…There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an… | 06/08/2022Open, Classified |
| Z-1467-2022 Class II | TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the…Electrical component failure within the control unit. The observed failure mode is a loss of function of the… | 06/07/2022Open, Classified |
| Z-1322-2022 Class II | EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25…The affected staplers have the potential for the staple guide to not be securely attached to the instrument.… | 05/13/2022Open, Classified |
| Z-0514-2022 Class II | SonarMed AirWave Monitor Kit (Monitor, Sensor Cable, Power Cord), Item Code AW-M0001.…Prior to use on a patient, the device alarm speaker failed to annunciate on power up and the device falsely… | 12/22/2021Open, Classified |
| Z-0557-2022 Class II | Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter…The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon… | 12/17/2021Open, Classified |
| Z-0495-2022 Class II | LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837Customers reported that the device jaws were difficult to open or would not open following application on… | 12/06/2021Terminated |
| Z-0332-2022 Class II | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery…Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or… | 11/12/2021Open, Classified |
| Z-0353-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X3JADIJJManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0352-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X3ENDIUUManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0351-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X2ESDIECManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0350-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X1PLDIPCManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0349-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X1JADIJJManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0348-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X1ENNISBManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0347-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X1ENDIUUManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0346-2022 Class I | Puritan Bennett 980 Series Ventilator, 980X1ENDIPCManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0345-2022 Class I | Puritan Bennett 980 Series Ventilator,980X1ENAIQCManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0344-2022 Class I | Puritan Bennett 980 Series Ventilator, 980U3ESDIUUManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0343-2022 Class I | Puritan Bennett 980 Series Ventilator, 980U1ESDIUCManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0342-2022 Class I | Puritan Bennett 980 Series Ventilator, 980U1ENASAAManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0341-2022 Class I | Puritan Bennett 980 Series Ventilator, 980S3ENDICUManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0340-2022 Class I | Puritan Bennett 980 Series Ventilator, 980S1ENDICUManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0339-2022 Class I | Puritan Bennett 980 Series Ventilator, 980A3ENNISBManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0338-2022 Class I | Puritan Bennett 980 Series Ventilator, 980A1ENNISBManufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may… | 11/04/2021Terminated |
| Z-0210-2022 Class II | Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation…The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt… | 09/29/2021Terminated |
| Z-2240-2021 Class II | Covidien Sonicision Reusable Generator-converts electrical power from the battery pack…Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device… | 06/23/2021Terminated |
| Z-2375-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2374-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2373-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2372-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2371-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2370-2021 Class II | Palindrome Precision RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2369-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 55cm, Sterile, Item Code 8888541155This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2368-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 44cm, Sterile, Item Code 8888541144This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2367-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 33cm, Sterile, Item Code 8888541133This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2366-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 28cm, Sterile, Item Code 8888541128This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2365-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 23cm, Sterile, Item Code 8888541123This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2364-2021 Class II | Palindrome RT Repair Kit 15 FR TAL 19cm, Sterile, Item Code 8888541119This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2363-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2362-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2361-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2360-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2359-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-2358-2021 Class II | Palindrome RT Chronic Catheter Kit Symmetrical Tip, Reverse-Tunneled 15 Fr/Ch (5.0 mm) x…This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and… | 05/28/2021Open, Classified |
| Z-1869-2021 Class II | HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for…The company was notified by their supplier of sterilization services for airway products in Italy of… | 04/29/2021Open, Classified |
| Z-1868-2021 Class II | Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated…The company was notified by their supplier of sterilization services for airway products in Italy of… | 04/29/2021Open, Classified |
| Z-1867-2021 Class II | Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product…The company was notified by their supplier of sterilization services for airway products in Italy of… | 04/29/2021Open, Classified |
| Z-1866-2021 Class II | Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single…The company was notified by their supplier of sterilization services for airway products in Italy of… | 04/29/2021Open, Classified |
| Z-1419-2021 Class II | Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with…Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility… | 03/23/2021Terminated |
| Z-1411-2021 Class II | Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting &…Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II… | 03/05/2021Open, Classified |
| Z-1385-2021 Class II | Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | 03/04/2021Terminated |
| Z-1384-2021 Class II | Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | 03/04/2021Terminated |
| Z-1383-2021 Class II | Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm -…Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload… | 03/04/2021Terminated |
| Z-1335-2021 Class II | BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used…The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the… | 02/26/2021Open, Classified |
| Z-1334-2021 Class II | CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used…The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the… | 02/26/2021Open, Classified |
| Z-1142-2021 Class II | Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product…incorrect device is contained in the package. The packaging label indicates that the device is for left side… | 01/13/2021Terminated |
| Z-0748-2021 Class II | Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3.…May contain a damaged internal component which could impede staple deployment and result in incomplete… | 11/23/2020Completed |
| Z-0747-2021 Class II | Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended…May contain a damaged internal component which could impede staple deployment and result in incomplete… | 11/23/2020Completed |
| Z-0515-2021 Class II | Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01…The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of… | 11/16/2020Open, Classified |
| Z-0425-2021 Class II | Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient…In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack… | 10/16/2020Open, Classified |
| Z-0009-2021 Class II | Covidien Best Practices Procedure Kits containing Auto Suture Endo GIA Universal Loading…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0008-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0007-2021 Class II | Endo GIA Auto Suture Universal Loading Unit, Item Code 030457 - Product Usage: The Endo…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0006-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0005-2021 Class II | Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - Product…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0004-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0003-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0002-2021 Class II | Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-0001-2021 Class II | Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code…The device staples may not properly form upon application preventing adequate hemostasis. Use of a product… | 08/12/2020Open, Classified |
| Z-2769-2020 Class II | Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use…This voluntary recall is being conducted following three customer reports of the device cannula detaching… | 06/26/2020Open, Classified |
| Z-2768-2020 Class II | Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use…This voluntary recall is being conducted following three customer reports of the device cannula detaching… | 06/26/2020Open, Classified |
| Z-2255-2020 Class II | Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No.…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | 05/12/2020Open, Classified |
| Z-2254-2020 Class II | Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No.…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | 05/12/2020Open, Classified |
| Z-2253-2020 Class II | Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage:…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | 05/12/2020Open, Classified |
| Z-2252-2020 Class II | Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage:…The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly… | 05/12/2020Open, Classified |
| Z-1994-2020 Class II | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1993-2020 Class II | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1992-2020 Class II | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1991-2020 Class II | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1990-2020 Class II | Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1989-2020 Class II | Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1988-2020 Class II | Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1987-2020 Class II | Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1986-2020 Class II | Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T -…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1985-2020 Class II | Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1984-2020 Class II | Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code:…Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/-… | 04/30/2020Terminated |
| Z-1447-2020 Class II | Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA…Sterile packaging may potentially be compromised, and use of products may result in increased risk for… | 02/10/2020Terminated |
| Z-1446-2020 Class II | Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB…Sterile packaging may potentially be compromised, and use of products may result in increased risk for… | 02/10/2020Terminated |
| Z-1264-2020 Class II | Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in…Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result… | 01/17/2020Terminated |
| Z-1300-2020 Class II | Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201There is a potential for packaging integrity issues impacting the humidity or sterility barrier of specific… | 12/18/2019Terminated |