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 3921–3940 of 38,428 recalls

September 4, 2024· Bard Peripheral Vascular Inc

Recalled Item: The EVSRF catheter is a sterile

The Issue: The Venclose" RF Ablation Catheters may have been

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline CENTRAL CATHETER INSERTION TRA

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline TUBAL LIGATION PACK

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: XXX

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

Class II — Potential Health HazardOngoing
September 4, 2024· Olympus Corporation of the Americas

Recalled Item: Olympus Electrosurgical Generator

The Issue: There was an increase in complaints indicating an

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline DENTAL PACK

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline CHEST TUBE INSERTION TRAY ADUL

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion OB TRAY

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline EYE PACK

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline AMBULATORY MINI PACK

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kits

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline brand medical procedure convenience kit

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Medline DIALYSIS PACK

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Centurion EP LAB INSTRUMENT KIT

The Issue: It has been determined that certain Convenience kits

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

Class II — Potential Health HazardOngoing
September 4, 2024· B-K Medical A/S

Recalled Item: bk3000

The Issue: The internal power connections at the power inlet

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

Class II — Potential Health HazardOngoing