Browse Device Recalls
3,629 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,629 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 3,629 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, pressure-r... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, PEEP valve ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40inch oxygen reservoir tubing, filt... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, filter Prod... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, 40" oxygen reservoir tubing 6/cs ... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usag... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 27, 2017 | AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing, pre... | The mask component on various lots of the resuscitation devices have been identified as having th... | Class I | Vyaire Medical |
| Apr 26, 2017 | Absorb Bioresorbable Vascular Scaffold (BVS) system (Australia). The Absorb ... | Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System... | Class I | Abbott Vascular |
| Apr 25, 2017 | Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS... | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a pot... | Class I | Vascular Solutions, Inc. |
| Apr 24, 2017 | Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053... | Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor... | Class I | Respironics California Inc |
| Apr 20, 2017 | 10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion a... | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... | Class I | EBI Patient Care, Inc. |
| Apr 20, 2017 | 10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal f... | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Im... | Class I | EBI Patient Care, Inc. |
| Mar 31, 2017 | ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Seri... | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Oscor, Inc. |
| Mar 31, 2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ... | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Oscor, Inc. |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... | Class I | Newport Medical Instruments Inc |
| Mar 22, 2017 | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 101... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endova... | There have been five reports of graft thrombosis/occlusion during global commercial use, each fo... | Class I | Cook Medical Incorporated |
| Mar 22, 2017 | NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 101244... | Products from the identified lots may exhibit difficulty in removing the protective balloon sheat... | Class I | Abbott Vascular |
| Mar 22, 2017 | Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065... | ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detac... | Class I | ReFlow Medical |
| Mar 10, 2017 | HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... | In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... | Class I | Heartware |
| Feb 24, 2017 | HeartStart MRx Monitor/Defibrillator, Model numbers: M3535A (M3535ATZ) M3536... | HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior when operating using a si... | Class I | Philips North America, LLC |
| Feb 22, 2017 | The Medtronic StrataMR adjustable valves and shunts are designed to provide c... | Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the Strata... | Class I | Medtronic Neurosurgery |
| Feb 16, 2017 | 7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, P... | Merit Medical Systems, Inc. announces a voluntary field action for sheaths included with the 7F P... | Class I | Merit Medical Systems, Inc. |
| Feb 3, 2017 | HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... | Product recall of all HVAD Controllers currently on the market and to exchange them for the next... | Class I | Heartware |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 13, 2017 | The LIFEPAK 1000 defibrillator is intended for use by personnel who are autho... | The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off... | Class I | Physio-Control, Inc. |
| Jan 12, 2017 | LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monit... | The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer b... | Class I | Physio-Control, Inc. |
| Dec 20, 2016 | Comprehensive Reverse Shoulder System Humeral Tray Model 115340 | Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fractu... | Class I | Zimmer Biomet, Inc. |
| Dec 2, 2016 | Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage:... | Complaints of sheath separation, kinking, and/or tip damage during use. | Class I | BARD PERIPHERAL VASCULAR, INC |
| Dec 2, 2016 | Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-... | Complaints of sheath separation, kinking, and/or tip damage during use. | Class I | BARD PERIPHERAL VASCULAR, INC |
| Dec 2, 2016 | Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/... | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. | Class I | CareFusion 303, Inc. |
| Dec 2, 2016 | Halo One 5F Introducer Sheath 10 cm 5 pack Product Code: HAL510F Product ... | Complaints of sheath separation, kinking, and/or tip damage during use. | Class I | BARD PERIPHERAL VASCULAR, INC |
| Nov 23, 2016 | NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Prod... | A drift of the performance with the BK test (BK virus, worst case application) was observed for s... | Class I | BioMerieux SA |
| Nov 23, 2016 | MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS... | A drift of the performance with the BK test (BK virus, worst case application) was observed for s... | Class I | BioMerieux SA |
| Oct 21, 2016 | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artif... | The Main Printed Circuit Board Assembly (PCBA) of the affected Freedom Drivers may fail and cause... | Class I | SynCardia Systems Inc. |
| Oct 21, 2016 | Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Mul... | The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to r... | Class I | Centurion Medical Products Corporation |
| Oct 10, 2016 | Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, C... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
| Oct 10, 2016 | Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quad... | St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronizatio... | Class I | St Jude Medical Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.