Browse Device Recalls

223 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 223 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 223 FDA device recalls.

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DateProductReasonClassFirm
Jul 26, 2012 Interface module for CDl System 500 Product Usage: The Interface Module f... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 Serial interface module RS-232 Product Usage: The System 1 provides perfu... Terumo Cardiovascular Systems has received reports of malfunctions involving the loss of data tra... Class II Terumo Cardiovascular Systems Corporation
Jul 26, 2012 System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C) on December 2, 2010 (Recall#... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump malfunctio... Class II Terumo Cardiovascular Systems Corporation
Jun 25, 2012 System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Cardiovascular Systems (Terumo CVS) has received reports of various roller pump occlusion ... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicat... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicate... Terumo Cardiovascular Systems (Terumo CVS) received eight complaints since September 2008 of driv... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 System 1 Base, 220/240V The Terumo Advanced Perfusion System 1 is indicated... Terumo Advanced Perfusion System 1 battery charge is being depleted faster than expected during p... Class II Terumo Cardiovascular Systems Corporation
Jun 22, 2012 Central Control Module for System 1: System 1 Base, 100/120V 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 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

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.