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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
Dec 28, 2020 Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixatio... Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. Class II New Standard Device Inc
Jun 8, 2020 1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External P... 1.8mm truss wires are being removed to facilitate the introduction of 2.0mm truss wires. The incr... Class II New Standard Device Inc
Aug 14, 2019 Metalogix Slotted 90 Tubular Wrench x 10mm REF 900104 LOT A29618A Due to manufacturing processing error, wrench causing stripping when torqueing nuts. Class II New Standard Device Inc
Jul 23, 2019 'n'-Hole Post which is a component of the Revolution External Fixation System... The threads on posts stripping out when tensioned during application process. Class II New Standard Device 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.