Browse Device Recalls

360 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 360 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 360 FDA device recalls.

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DateProductReasonClassFirm
Jun 8, 2012 Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ... Class II Stryker Instruments Div. of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL28C Beds are intended for medical purposes in both gen... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in ... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 17, 2012 GoBed+ . Model FL20E Beds are intended for medical purposes in both genera... An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... Class II Stryker Medical Division of Stryker Corporation
May 24, 2011 Neptune¿ 2 Rover - ULTRA ~230V ~ 50 Hz 12A REF 0702-002-000, Rx Caution, con... Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... Class II Stryker Instruments Div. of Stryker Corporation
May 24, 2011 Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, co... Beginning May 24, 2011 Stryker Neptune 2 (N2) Waste Management Systems castors were replaced with... Class II Stryker Instruments Div. of Stryker Corporation

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.