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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601238, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601224, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Nov 23, 2020 APEX Compounding System Control Panel Module, REF: 601237, Product Code AX100... There is the potential for the compounding system to not immediately interrupt compounding and al... Class II B Braun Medical, Inc.
Dec 5, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... B. Braun Medical Inc. is informing our customers of a field correction previously performed to ad... Class II B Braun Medical, Inc.
Nov 14, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class I B Braun Medical, Inc.
Oct 31, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... This notice is being provided in follow up to the field correction initiated by B. Braun Medical ... Class II B Braun Medical, Inc.
Oct 24, 2012 Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump I... B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. Th... Class II B Braun Medical, 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.