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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 24, 2024 | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the f... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jun 3, 2024 | Curved, super elastic cement delivery needle that passes through the cannula ... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Jun 3, 2024 | This product is a single use sterile device that is used to direct the lesion... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Jun 3, 2024 | The Non-Sterile Flyte hood covers the user s head and neck region and is inte... | Expired Products distributed to customers | Class II | Stryker Corporation |
| Sep 13, 2023 | Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposa... | Expired product distributed | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM 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, 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 |
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.