Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 37501–37520 of 38,428 recalls

June 25, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 220/240V. The Terumo Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 25, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 100/120V The Terumo Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) has received reports

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) received eight complaints

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1

The Issue: Terumo Cardiovascular Systems (Terumo CVS) received eight complaints

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 Electronic O2 Blender/Analyzer. The...

The Issue: Terumo Cardiovascular Systems (Terumo CVS) received two complaints

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Central Control Module for System 1: System 1 Base

The Issue: Terumo CVS has received reports of the Central

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 System 1 Base

The Issue: Terumo Cardiovascular Systems (Terumo CVS) received two complaints

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 System 1 Base

The Issue: Terumo Cardiovascular Systems (Terumo CVS) received two complaints

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Central Control Module for System 1: System 1 Base

The Issue: Terumo CVS has received reports of the Central

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base

The Issue: Terumo Advanced Perfusion System 1 battery charge is

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 22, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base

The Issue: Terumo Advanced Perfusion System 1 battery charge is

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 System 1 Base

The Issue: Terumo Cardiovascular Systems has received reports of several

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 System 1 Base

The Issue: Terumo Cardiovascular Systems has received reports of several

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base

The Issue: Terumo¿ Advanced Perfusion System 1 has displayed a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: System 1 Base

The Issue: Terumo¿ Advanced Perfusion System 1 has displayed a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Elekta, Inc.

Recalled Item: Focal SIM Planning of radiation therapy

The Issue: Incorrect patient shift directions when the Setup reference

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 21, 2012· Elekta, Inc.

Recalled Item: Monaco Product Usage: Planning of radiation therapy

The Issue: Incorrect patient shift directions when the Setup reference

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 20, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens syngo.plaza Radiological Image Processing System Usage: Radiological...

The Issue: Firm has become aware of an unintended behavior

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 20, 2012· Gulf South Medical Supply Inc

Recalled Item: Select Medical Products Vinyl Powder-Free Exam Gloves

The Issue: Gulf South Medical Supply recalled their Select Medium

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
June 20, 2012· Philips Healthcare Inc.

Recalled Item: Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A

The Issue: Therapy Cable Connection wear may lead to a

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated