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
Dec 18, 2018 Cochlear Baha 5 Sound Processor Tamper Proof Battery Door (3 pcs.) Product was packaged with the Incorrect tamper proof battery door. Class II Cochlear Americas Inc.
Jun 5, 2015 Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear N... Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736... Class II Cochlear Americas Inc.
Apr 9, 2014 Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure th... Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imper... Class II Cochlear Americas 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.