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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 20, 2021 Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number ... The current IFU specifies a shelf-life of one week after resuspension of the RPC Buffer when stor... Class II Biomeme, Inc.
Jan 5, 2021 Nucleic acid-based in vitro diagnostic devices for the detection of 2019-nove... Users cannot complete testing due to a sign-error in the software component that controls the fil... Class III Biomeme, Inc.
Oct 23, 2020 The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnost... The firm has become aware of nine reports by a single customer that the software made false posit... Class II Biomeme, 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.