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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
Jan 20, 2023 Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart R... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate M... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD
Jan 20, 2023 Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Mo... Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the hea... Class III SUREPULSE MEDICAL LTD

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.