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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, 2018 Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage:... Automated external defibrillators may not fully meet IPx5 water ingress specification. The device... Class II Philips Electronics North America Corp.
Mar 14, 2018 Philips HeartStart (HS1) Onsite/Home AED An issue with one of the electric components (a resistor) could result in the device not deliveri... Class II Philips Electronics North America Corp.
Mar 14, 2018 Philips HeartStart FRx AED. An issue with one of the electric components (a resistor) could result in the device not deliveri... Class II Philips Electronics North America Corp.

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.