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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
Sep 19, 2014 MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag... Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer Class II Orthohelix Surgical Designs Inc
Oct 30, 2012 Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill B... The firm was notified by a customer that there was a burr on the inside end of the drill bit resu... Class II Orthohelix Surgical Designs Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs 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.