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 36001–36020 of 38,428 recalls

March 26, 2013· GE Healthcare, LLC

Recalled Item: GE

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
March 26, 2013· GE Healthcare, LLC

Recalled Item: GE PET Discovery 610

The Issue: GE Healthcare has recently become aware of a

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

Class II — Potential Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: A) Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Cardinal Health, Medical Products & Services

Recalled Item: Presource PBDS

The Issue: Various Presource Kits contain a pre-assembled Filter and

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

Class I — Serious Health HazardTerminated
March 26, 2013· Owens & Minor Distribution, Inc.

Recalled Item: MediChoice¿ Rayon Tipped OB/GYN Applicator

The Issue: Owens & Minor Distribution, Inc. is conducting a

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

Class II — Potential Health HazardTerminated
March 26, 2013· Varian Medical Systems, Inc. Oncology Systems

Recalled Item: Varian brand RPM Respiratory Gating System

The Issue: Varian has identified an anomaly with the RPM

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

Class II — Potential Health HazardTerminated
March 26, 2013· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences Crimpers

The Issue: Holes in the sterile barrier pouch may be

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

Class II — Potential Health HazardTerminated
March 26, 2013· Edwards Lifesciences, LLC

Recalled Item: Edwards Lifesciences Crimpers

The Issue: Holes in the sterile barrier pouch may be

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

Class II — Potential Health HazardTerminated