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 35861–35880 of 38,428 recalls

April 12, 2013· Becton Dickinson & Co.

Recalled Item: BBL DrySlide PYR Kit

The Issue: In-vitro diagnostic agents were placed into incorrect packaging

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Push...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Coloplast Manufacturing US, LLC

Recalled Item: Rostorelle L

The Issue: Mislabeling

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

Class II — Potential Health HazardTerminated
April 12, 2013· Progressive Medical Inc

Recalled Item: Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -...

The Issue: Product coatings require 510K approval

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

Class II — Potential Health HazardTerminated
April 12, 2013· Covidien LLC

Recalled Item: Curity Staple Remover Kit

The Issue: On March 26, 2013 Covidien received a recall

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

Class III — Low RiskTerminated