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 3581–3600 of 38,428 recalls

October 10, 2024· Boston Scientific Corporation

Recalled Item: Boston Scientific POLARx FIT BALLOON CATHETER LT OUS

The Issue: Boston Scientific is updating the instructions for use

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

Class I — Serious Health HazardOngoing
October 10, 2024· Boston Scientific Corporation

Recalled Item: Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number...

The Issue: Boston Scientific is updating the instructions for use

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

Class I — Serious Health HazardOngoing
October 10, 2024· Boston Scientific Corporation

Recalled Item: Boston Scientific POLARx FIT BALLOON CATHETER ST OUS

The Issue: Boston Scientific is updating the instructions for use

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

Class I — Serious Health HazardOngoing
October 10, 2024· Boston Scientific Corporation

Recalled Item: Boston Scientific POLARx BALLOON CATHETER ST 28MM OUS

The Issue: Boston Scientific is updating the instructions for use

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

Class I — Serious Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: PORT INSERTION PACK

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) ANGIO PACK #2

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: L&D MINOR PACK

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) BURN

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· The Metrix Company

Recalled Item: Imed Products Imed EVA BAG

The Issue: A limited number of IV bags have been

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) TRACH TOTE

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing
October 9, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF

The Issue: Medline is recalling medical convenience manufactured using certain

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

Class II — Potential Health HazardOngoing