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 23481–23500 of 38,428 recalls

June 22, 2017· NeuroLogica Corporation

Recalled Item: The GC80 Digital X-ray Imaging System

The Issue: An image was obtained with over exposure during

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom GENERAL PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom SHOULDER ARTHROSCOPY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom DAVINCI PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom KNEE ARTHROSCOPY PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom MINOR PROCEDURE 6A convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom OBSTETRICAL PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom NEURO PK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom EXTREMITY PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom PLASTIC BASIN PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom PACEMAKER PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom ORTHO TRAY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom CATH PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom PACEMAKER PACK (CARDIOLOGY) convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom LOWER EXTREMITY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom GYN LAPAROSCOPY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom UPPER EXTREMITY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom DJ'S VASCULAR/NEURO TRAY convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom LAMINECTOMY PACK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated
June 22, 2017· Avid Medical, Inc.

Recalled Item: AVID TruCustom ELECTRO PHYSIOLOGY PK convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardTerminated