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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Jan 10, 2013 Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidew... The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the meas... Class II Extremity Medical LLC
Mar 22, 2012 Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. T... Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/... Class II Extremity Medical LLC
Apr 25, 2011 IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer S... Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was n... Class II Extremity Medical LLC
Apr 13, 2011 IO Fix IntraOsseous Fixation System; Extremity Medical. www.extremitymedical... Product Event Reports revealed that lag screw passes through washer (e.g. X-Post) intra-operatively. Class II Extremity Medical LLC

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.