Browse Device Recalls

950 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 950 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 950 FDA device recalls in MI.

Clear
DateProductReasonClassFirm
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
Jul 17, 2012 RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jul 17, 2012 RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable... Stryker has received 6 complaints that the 5mm needle was placed in 10 mm package and 10 mm needl... Class II Stryker Instruments Div. of Stryker Corporation
Jul 13, 2012 syngo Dynamics Version 9.5 If multiple uncompressed images/clips are sent to the syngo Dynamics server, around the same time... Class II Siemens Medical Solutions, USA, Inc
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair. The Powered MOV Chair m... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker Corporation
Jun 27, 2012 Powered Mobility Offers Versatility (M¿V)TM Chair The Powered MOV Chair mo... Paramed Corporation (d/b/a, Descent Control Systems), a manufacturer and distributor of patient t... Class II Stryker Medical Division of Stryker 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 Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed... Class II Safe N Simple, LLC
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
Jun 8, 2012 Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ... Class II Stryker Instruments Div. of Stryker Corporation
May 17, 2012 Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both ... 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 17, 2012 Go Bed II+ Model FL28C Beds are intended for medical purposes in both gen... 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 17, 2012 Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in ... 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 17, 2012 Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in ... 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 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

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.