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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
Jul 1, 2025 JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside ... Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potentia... Class II North American Rescue LLC.
Aug 27, 2021 10 ga ARS Decompression Needle, Part Number ZZ-0298 The device includes the incorrect Instructions for Use. Class II North American Rescue LLC.
Aug 21, 2020 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... Lack of sterility assurance of the 30-0171 Class II North American Rescue 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.