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 3801–3820 of 38,428 recalls

September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard UROLOGY LAPAROTOMY PACK - Medical convenience kits Model Number:

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard ABDOMINAL PROCEDURE - Medical convenience kits Model Number: GRAN015-06

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard CATH LAB PACK - Medical convenience kits Model Number: VANW016-05

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number:

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard CPT PEDS ADULT CH PACK - Medical convenience kits

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard HEART CATH LAB PK

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· AVID Medical, Inc.

Recalled Item: Halyard EP PACK - Medical convenience kits Model Number: VANW018-06

The Issue: Foreign Object Contamination

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

Class II — Potential Health HazardOngoing
September 20, 2024· Integra LifeSciences Corp.

Recalled Item: SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties

The Issue: Identified higher-than-expected levels of endotoxin within the raw

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

Class II — Potential Health HazardOngoing
September 20, 2024· Maquet Cardiovascular, LLC

Recalled Item: VasoView HemoPro Endoscopic Vessel Harvesting System

The Issue: There were reports of the silicone detaching from

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

Class I — Serious Health HazardOngoing
September 20, 2024· Integra LifeSciences Corp.

Recalled Item: SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and

The Issue: Identified higher-than-expected levels of endotoxin within the raw

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

Class II — Potential Health HazardOngoing