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Browse Device Recalls

53 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 53 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 53 FDA device recalls.

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DateProductReasonClassFirm
Jun 11, 2014 Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile. T... Lack of Sterility Assurance Class II PIONEER SURGICAL TECHNOLOGY, INC.
Jun 14, 2013 Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only... The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. Class II PIONEER SURGICAL TECHNOLOGY, INC.
Sep 10, 2012 STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERIL... Some set screw thread profiles were found not to be within specifications. Class II PIONEER SURGICAL TECHNOLOGY, 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.