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 29481–29500 of 38,428 recalls

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* Closed Suction Systems 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* 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* 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
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: 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· Synthes (USA) Products LLC

Recalled Item: VEPTR Vertical Expandable Prosthetic Titanium Rib

The Issue: The last hole on certain VEPTR Inferior Cradles

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* 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* 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: 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· Synthes (USA) Products LLC

Recalled Item: Synthes Trauma Ex-Fix System (Small

The Issue: Labeling changes were made related to MR conditions

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

Class II — Potential Health HazardTerminated
July 29, 2015· Synthes (USA) Products LLC

Recalled Item: Synthes Sciatic Nerve Retractor and Sciatic Nerve Retractor Long

The Issue: for micropores to form, allowing fluid to

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

Class II — Potential Health HazardTerminated
July 28, 2015· OrthoPediatrics Corp

Recalled Item: 3.5mm Non Locking Cortical Screw

The Issue: The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical

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

Class II — Potential Health HazardTerminated
July 28, 2015· Biomet, Inc.

Recalled Item: Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.

The Issue: The device was assembled without screw hole plugs

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

Class II — Potential Health HazardTerminated