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Browse Device Recalls

161 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 161 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 161 FDA device recalls.

Clear
DateProductReasonClassFirm
May 23, 2013 Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single us... Based on an accelerated aging test for this product packaging, there is an indicator of potential... Class II Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012 RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012 RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070... 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 8, 2012 Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M... 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 8, 2012 Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t... 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 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 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.