Browse Device Recalls

353 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 353 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 353 FDA device recalls.

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DateProductReasonClassFirm
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catal... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Sep 11, 2023 Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Ca... An error was identified on the expiration date of the product label. The shelf life for the produ... Class II Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-200 Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 300900000000, Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-Z-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZX-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LEX-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCurity bed series, model number 3009, item number: 3009PX-ZMX-600. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-ZM-450. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-L-100. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 30, 2023 ProCuity bed series, model number 3009, item number: 3009PX-LE-400. Patient beds are missing test values for electrical safety tests presenting risk of tissue burn ... Class II Stryker Medical Division of Stryker Corporation
Aug 23, 2023 Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462 Expired Product distributed Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakawa... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, All... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Aug 7, 2023 Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... Class II Stryker Corporation
Jul 10, 2023 SurgiCount+ Software Application-indicated as an adjunctive technology for au... Potential for current software to miscount when scanning in multiple sponge-products from the sam... Class II Stryker Corporation
Jun 28, 2023 The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be us... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone ... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
Jun 28, 2023 stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone c... There is potential the device inside the package may not match the product information on the out... Class II Stryker Corporation
May 24, 2023 Power-PRO 2- A powered ambulance cot that consists of a platform, including a... Base leg assembly may bend and result in difficulty engaging/disengaging from fastener, difficult... Class II Stryker Medical Division of Stryker Corporation
Mar 2, 2023 SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray... Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output iss... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II Stryker Corporation
Mar 1, 2023 Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,... Not able to achieve desired pressure and not holding pressure result from two different causes wh... Class II 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.