Browse Device Recalls
949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 949 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 949 FDA device recalls in MI.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 24, 2024 | Stryker iBur 4.0mm Precision Round, Distal Bend- intended to cut bone in the... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 4.0mm 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 4.0mm 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 |
| Jul 24, 2024 | Stryker iBur 3.0mm Precision Match Head, 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 |
| Jul 24, 2024 | Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 5.0mm 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 |
| 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 | Endoscopic Kittner Blunt Dissecting Instrument, Intended to be used for blunt... | The affected products may have been packaged with a defect in the sterile barrier seal. As a resu... | Class II | ASPEN SURGICAL |
| 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 |
| Feb 20, 2024 | Cardiovascular Procedure Kits that include High Crack Check Valve PN 205307A ... | Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly op... | Class II | Terumo Cardiovascular Systems Corporation |
| Oct 11, 2023 | NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal l... | May have increased water path restriction within the heat exchanger, leading to degraded heat exc... | Class II | Mc3 Inc |
| Oct 11, 2023 | Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multipl... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Curaplex manual resuscitators with integrated manometer, multiple accessory c... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal lif... | May have increased water path restriction within the heat exchanger, leading to degraded heat exc... | Class II | Mc3 Inc |
| Oct 11, 2023 | Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple ... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multipl... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, mult... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multi... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, m... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| Oct 11, 2023 | Medline manual resuscitators with integrated manometer, multiple accessory co... | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreath... | Class II | SunMed Holdings, LLC |
| 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 |
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.