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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Oct 10, 2013 Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro... A review of complaints identified a trend for drills breaking. Class II Cayenne Medical Inc.
Jul 11, 2013 AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (... Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. Class II Cayenne Medical Inc.
Apr 28, 2010 AperFix Femoral Implant Coring Removal Drill, labeled as the following: ... A review of product complaints in 2010 identified a trend for the Coring Removal Drill of prematu... Class II Cayenne Medical 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.