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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
Oct 27, 2022 Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE, REF 73-8020,... Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for ste... Class II Southmedic, Inc.
May 25, 2021 OxyMask O2 Adult REF OM-1125-14 Potential for oxygen tubing to disconnect from mask or loosen. Disconnected tubing results in ... Class II Southmedic, Inc.
Nov 6, 2017 Southmedic Sterile Disposable Scalpel Rx only Scalpels are intended to be ... Scalpels lot contains non-sterile products labeled as sterile. Class II Southmedic, Inc.
Oct 17, 2017 Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 ma... Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. Class II Southmedic, 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.