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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Sep 9, 2025 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I The unexpected internal fault / system diagnostic error to result when a rapid succession of butt... Class I NOXBOX LTD
Sep 9, 2025 NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I Fluctuations may be more likely to occur if the total flow through the device sensor (used by the... Class I NOXBOX LTD
Jul 19, 2023 NOxBOXi Nitric Oxide Delivery System Replacement of the internal Sample Pump due to high failure rates. Class II NOXBOX LTD
May 3, 2023 NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Del... Device may experience malfunctions due to misalignment of the check valve in the manifold. If the... Class I NOXBOX 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.