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 29461–29480 of 38,428 recalls

July 29, 2015· BD LIFE SCIENCES

Recalled Item: Software version 4.44A utilized on the BD MAX System

The Issue: The BD MAX System software version 4.44A contains

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

Class II — Potential Health HazardTerminated
July 29, 2015· Biomet 3i, LLC

Recalled Item: UCLA Abutment Hexed Castable Cylinder 3.4mm Are accessories to endosseous

The Issue: MUCC2, non-hexed, castable abutment cylinders, has been labeled

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

Class II — Potential Health HazardTerminated
July 29, 2015· Nico Corp.

Recalled Item: NICO Myriad Console Model number NN-7000 The Myriad System is

The Issue: Two cables within the console were inadvertently twisted

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: NovaPlus Trach Care* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Turbo-Cleaning Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: NovaPlus Trach Care* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Wet Pak* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Wet Pak* Closed Suction System for Pediatrics

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Neonates/Pediatrics

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Wet Pak* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Turbo-Cleaning Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Multi-Access Port Replacement Catheter for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Turbo-Cleaning Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Turbo-Cleaning Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated
July 29, 2015· Halyard Health, Inc

Recalled Item: KimVent* Multi-Access Port Closed Suction System for Adults

The Issue: The thumb valve of some KIMVENT Closed Suction

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

Class II — Potential Health HazardTerminated