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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 89 cm... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 16, 2024 Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 127 c... There is over-molding that stabilizes the connection between the cable and cable-entry on the mat... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Dec 4, 2024 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and T... Class II Augustine Temperature Management, LLC
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Feb 15, 2024 Augustine Surgical Inc. HotDog Return Electrode accessory connector cables, M... Users were experiencing the following error message (M-0B-125) stated Check Neutral Electrode Co... Class II Augustine Temperature Management, LLC
Mar 14, 2022 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... Class II Augustine Temperature Management, LLC
Mar 14, 2022 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... Class II Augustine Temperature Management, LLC
Mar 14, 2022 Hillrom Temperature Management Controller, MP, Model # 2083516; used in conju... HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... Class II Augustine Temperature Management, LLC
Mar 14, 2022 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... Class II Augustine Temperature Management, LLC
Mar 14, 2022 Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Contr... HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controlle... Class II Augustine Temperature Management, LLC

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.