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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Nov 3, 2020 STOPCON Disposable Valves Set-Single Use Valves (suction-/air-water-/biopsy... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY SUR... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R (Air-... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water, Suction, Bio... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biops... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-Contains Suction, Air/Water, Biopsy ... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve,Suction Val... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R (Air-Wa... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 Andorate Disposable Endoscope Valves Set-5-piece Valve, Connector and Cleanin... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED
Nov 3, 2020 ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corp... Suction button is reported sticky and/or broken during or after the procedure, may cause prolonge... Class II GA HEALTH COMPANY LIMITED

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.