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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Mar 31, 2023 Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 9... The liquid buffer component in the affected test kit lots was determined to have bacterial contam... Class I SD Biosensor, Inc.
Jan 31, 2022 STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rap... Illegal importation of COVID-19 AG Test kits into the U.S. The COVID-19 Ag Test are not approved,... Class I SD Biosensor, 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.