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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
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 4, 2014 HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) w... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 Heart Mate II Pocket Controllers removed from packaging Product Usage: ... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMat... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 HeartMate II System Controller Product Usage: HeartMate II is a mechanica... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Aug 22, 2013 Surgicutt fully automated incision making device for bleeding time determinat... ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L... Class II ITC-Nexus Dx
Jul 16, 2013 ProTime Microcoagulation System; PROTIME CUVETTE AND PROTIME3 CUVETTE; Store ... The products may have been stored at temperatures outside their required storage conditions. Class II Assuramed

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.