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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
Jan 20, 2017 CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is Cav... Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the ... Class II Metrex Research, LLC.
Feb 6, 2012 CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate bra... Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected ... Class II Metrex Research, LLC.
Sep 20, 2011 Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... Class II Metrex Research, 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.