Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Dec 26, 2025 Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 PREGNANCY TEST 24CT Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Condoms, labeled as: TROJAN MAGNUM CONDOMS 6/DSP BLACK, TROJAN LUBRICATED CO... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE ... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION INC
Dec 26, 2025 Feminine hygiene products, labeled as: KOTEX FREEDOM MAXI NO WINGS 48CT, A... Potential exposure of rodents and rodent activity in the distribution center. Class II GOLD STAR DISTRIBUTION 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.