Browse Device Recalls
952 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 952 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 952 FDA device recalls in MI.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 17, 2012 | GoBed+ . Model FL20E Beds are intended for medical purposes in both genera... | An adverse trend of scale and bed exit service reports/complaints were detected for the GoBed+, G... | Class II | Stryker Medical Division of Stryker Corporation |
| May 9, 2012 | CPB CATHETER KIT-DR BARTLES Product Usage: The Sarns Cardioplegia Cannula... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS ANTEGRADE: CARDIOPLEGIA CANNULA: ROOT INFUSION VENT/CATHETER WITH 14- G... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SPECIALTYCARE - HUDGENS. The Sarns High Flow Aortic Arch Cannula is indica... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | MAYO MN XCOATED 3/8X1/2 AV Product Usage: The Sarns Cardioplegia Cannula ... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT-DR GERHARDT Product Usage: The Sarns Cardioplegia Cannul... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannu... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CUSTOM CPB CATHETER KIT-DR. Product Usage: The Sarns Cardioplegia Cannula... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | XC HEART/LUNG PACK W/SX25RX Product Usage: The Sarns Cardioplegia Cannula... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is ind... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT- DR.VAN TRIGHT. The Sarns High Flow Aortic Arch Cannula i... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT- DR OWEN Product Usage: The Sarns Cardioplegia Cannula a... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | X-COATED FX25RW H/L PACK Product Usage: The Sarns Cardioplegia Cannula an... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | X-COATED SMALL PATIENT PACK Product Usage: The Sarns Cardioplegia Cannula... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM (20 FR) 00 WITH 3/8" CONNECTOR,SUTURE... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Can... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | X-COATED H/L PK W/FX15RW40 Product Usage: The Sarns Cardioplegia Cannula ... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHI... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | CPB CATHETER KIT-DR VANTRIGHT Product Usage: The Sarns Cardioplegia Cannu... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | INDIANA/OHIO HEART Product Usage: The Sarns Cardioplegia Cannula and Card... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 1... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) 00 WITH 3/8" CONNECTOR, CM MA... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM (20 FR) 00 WITH 3/8" CONNECTOR, 1... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | 24FR FLEX ART CANN NON STERILE. The Sarns High Flow Aortic Arch Cannula i... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 12-GAUGE BLU... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM (24 FR) WITH 3/8" CONNECTOR,SUTURE RI... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Ve... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM (16 FR) 00 WITH 3/8" CONNECTOR, 7... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM (22 FR) 00 WITH 3/8" CONNECTOR,SUTURE... | During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Sy... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | X-COATED TRANSPLANT PACK Product Usage: The Sarns Cardioplegia Cannula an... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| May 9, 2012 | Sarns Antegrade Cardioplegia Cannula: ROOT INFUSTION VENT CATHETER WITH 12 GA... | During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Ter... | Class II | Terumo Cardiovascular Systems Corporation |
| Mar 13, 2012 | Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two p... | Decrease reactivity of R 1 component. | Class II | Medtest Holdings, Inc. |
| Feb 21, 2012 | The brand name of the device is AlgiNot, a dental impression material. Produ... | The firm recalled the product because it may cure harder than expected within the shelf life, wh... | Class II | Kerr Corporation |
| Feb 15, 2012 | Pointe Scientific Hitachi AST Reagent R1 : PE plastic bottle w/PP plastic ... | A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates li... | Class III | Medtest Holdings, Inc. |
| Feb 6, 2012 | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate bra... | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected ... | Class II | Metrex Research, LLC. |
| Oct 19, 2011 | Pointe Scientific Liquid Creatine Kinase Reagent Set Device is a kit compris... | Linear performance information in product insert does not match that listed in the approved prema... | Class III | Medtest Holdings, Inc. |
| Sep 20, 2011 | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... | Class II | Metrex Research, LLC. |
| Jul 8, 2011 | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set Model Number(s... | Pointe Scientific Lactate Dehydrogenase (Liquid) Reagent Set stability claim is not being met. | Class II | Medtest Holdings, Inc. |
| 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 |
| Nov 22, 2010 | The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ... | Incorrect control range in product labeling | Class III | Medtest Holdings, Inc. |
| Nov 1, 2010 | Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood... | Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope... | Class II | Terumo Cardiovascular Systems Corporation |
| Jul 27, 2010 | Xoran Mini CT Scanner | A description of the defect in the product or the manner in which the product fails to comply wit... | Class II | Xoran Technologies, Inc. |
| Jul 27, 2010 | Xoran Minicat00202 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... | Class II | Xoran Technologies, Inc. |
| Jul 27, 2010 | Xoran MiniCAT00202 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... | Class II | Xoran Technologies, Inc. |
| Jul 27, 2010 | Xoran MiniCAT CT Scanner | A description of the defect in the product or the manner in which the product fails to comply wvi... | Class II | Xoran Technologies, Inc. |
| Jul 27, 2010 | Xoran Minicat00158 | The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do... | Class II | Xoran Technologies, Inc. |
| Dec 14, 2009 | Xoran MiniCAT CT Scanner ID ENT00001 | Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but ... | Class II | Xoran Technologies, Inc. |
| Oct 2, 2009 | Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservo... | Backplate reservoir holders were manufactured with an incorrect configuration of connector suppor... | Class II | Terumo Cardiovascular Systems 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.