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.

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DateProductReasonClassFirm
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.