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 36981–37000 of 38,428 recalls

September 25, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

Class II — Potential Health HazardTerminated
September 25, 2012· Alphatec Spine, Inc.

Recalled Item: ILLlCO¿ MIS Posterior Fixation System

The Issue: The firm initiated the recall because the stainless

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

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

Recalled Item: Perfusion System 8000

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

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

Class II — Potential Health HazardTerminated
September 25, 2012· Belmont Instrument Corporation

Recalled Item: Belmont Rapid Infuser

The Issue: Leak from a saline bag caused saline to

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

Class II — Potential Health HazardTerminated
September 25, 2012· Teleflex Medical

Recalled Item: Hem-o-lok Large Polymer Ligating Clips

The Issue: Product is being recalled due to the possibility

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

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

Recalled Item: Battery

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

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

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

Recalled Item: Battery

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

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

Class II — Potential Health HazardTerminated
September 24, 2012· Winco Mfg., LLC

Recalled Item: PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01

The Issue: The performance of the chemicals in the foam

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

Class II — Potential Health HazardTerminated
September 24, 2012· Winco Mfg., LLC

Recalled Item: Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01

The Issue: The performance of the chemicals in the foam

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

Class II — Potential Health HazardTerminated
September 24, 2012· Winco Mfg., LLC

Recalled Item: Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01

The Issue: The performance of the chemicals in the foam

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

Class II — Potential Health HazardTerminated
September 24, 2012· Winco Mfg., LLC

Recalled Item: PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01

The Issue: The performance of the chemicals in the foam

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

Class II — Potential Health HazardTerminated
September 24, 2012· Mindray DS USA, Inc. d.b.a. Mindray North America

Recalled Item: Mindray V12 Size: 320 mm X 320 mm X 450

The Issue: Mindray has identified an issue with the V

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

Class II — Potential Health HazardTerminated