Browse Device Recalls
204 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 204 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 204 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 22, 2012 | Terumo Advanced Perfusion System 1 System 1 Base, 220/240 V. The Terumo... | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo ... | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | Central Control Module for System 1: System 1 Base, 220/240V The Terumo Ad... | Terumo CVS has received reports of the Central Control Monitor (CCM) for Terumo Advanced Perfusio... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 22, 2012 | Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The el... | Terumo Cardiovascular Systems (Terumo CVS) received two complaints related to the Gas System for ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 21, 2012 | System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicat... | Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 21, 2012 | System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicat... | Terumo¿ Advanced Perfusion System 1 has displayed a Red X error message on multiple module icons ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 21, 2012 | Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo ... | Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 21, 2012 | Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo ... | Terumo Cardiovascular Systems has received reports of several issues that manifest themselves as ... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 20, 2012 | System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ... | During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa... | Class III | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Per... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Ad... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Pe... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular P... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modul... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular P... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Ad... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular P... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modul... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems Corporation |
| Jun 18, 2012 | Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Per... | Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Dete... | Class II | Terumo Cardiovascular Systems 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 |
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.