Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
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, 40inch oxygen reservoir tubing, PEEP... 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, 40 inch oxygen reservoir tubing, pr... 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, Infant, with mask, oxygen reservoir bag, pressure-reli... 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, Broselow Hinkle Kit Product Usage: The AirLife Res... 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, Broselow Hinkle Kit Product Usage: The AirLife Res... 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, 28inch large bore tubing Product ... 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, CO2 detector ... 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, Pediatric, with mask, oxygen reservoir bag, manometer,... 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, 28inch large bore tubing, pressure-... 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, manometer, PEE... 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, Replacement kit for outer shell, Broselow Product U... 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, Infant, with mask, oxygen reservoir bag, pressure-reli... 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, CO2 detector, ... 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, 28inch large bore tubing, 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, 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, oxygen reservoir bag, manometer P... 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, CO2 detector, ... 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 20, 2017 The Acumed Slide-Loc Anatomic Radial Head System is intended for use by surge... The firm initiates a voluntary removal and discontinue marketing of Slide-Loc Anatomic Radial Hea... Class II Acumed LLC
Apr 11, 2017 PARADYM Models: VR 8250, DR 8550, CRT-D 8750, RF VR 9250, RF DR 9550, RF CRT... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 INTENSIA Models: VR 124, DR 154, CRT-D 174 Product Usage: OVATIO VR 6250... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Apr 11, 2017 OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. Class II Sorin Group Italia SRL - CRF
Mar 31, 2017 Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM There is a risk that the pinion gear in the device could fail under extreme use cases. Class II Ethicon Endo-Surgery Inc
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 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; 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 28, 2017 GP161R; ELAN 4 1-RING DIAMOND BURR COARSE D2.0; GP162R; ELAN 4 1-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 GP321R; ELAN 4 2-RING DIAMOND BURR COARSE D2.3; GP322R; ELAN 4 2-RING DIAM... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
Mar 28, 2017 GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.D... Diamond particulates may break off the burr and fall into the surgical site. If the particles ar... Class II Aesculap Implant Systems LLC
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 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 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 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
Mar 7, 2017 AESCULAP MINOP InVent 30 Trocar System, non-sterile Product Usage:The Mi... Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sh... Class II Aesculap Implant Systems LLC
Mar 3, 2017 The PreludeSYNC Radial Compression Device is a sterile, single use disposable... Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compres... Class II Merit Medical Systems, Inc.
Mar 2, 2017 KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK... Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class III Microbiologics Inc
Mar 2, 2017 eCare Coordinator Product Usage: is software intended for use in data ag... eCareCoordinator (eCC) is intended for use in data aggregation, patient interaction facilitation,... Class II Philips Visicu
Mar 2, 2017 LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO... Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Class III Microbiologics Inc
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 20, 2017 Poly Component Trial, MPCS, packaged in the following sizes and configuration... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Poly Component Trial, PS, packaged in the following sizes and configurations:... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Poly Component Trial, CR, packaged in the following sizes and configurations:... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 20, 2017 Poly Component Trial, UCCS, packaged in the following sizes and configuration... The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken. Class II Medtronic Sofamor Danek USA Inc
Feb 17, 2017 various polyethylene implants Hips Active Articulation ArComXL Bearings A... Endotoxin levels higher than process maximum limits were discovered in the identified polyethylen... Class II Zimmer Biomet, 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.