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 35301–35320 of 38,428 recalls

June 19, 2013· Biosense Webster, Inc.

Recalled Item: 20-Pole LASSO Nav Catheter Eco

The Issue: Biosense Webster is recalling the 20-Pole LASSO NAV

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

Class II — Potential Health HazardTerminated
June 18, 2013· Invacare Corporation

Recalled Item: CHAMPION Medical Recliner

The Issue: There is a possibility of elevated temperatures in

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

Class II — Potential Health HazardTerminated
June 18, 2013· Aesculap, Inc.

Recalled Item: ProSpace Peek Implant 5 degree x 8.5 x 22 mm

The Issue: Aesculap Implant Systems, LLC initiated a recall of

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

Class II — Potential Health HazardTerminated
June 18, 2013· Hospira Inc.

Recalled Item: LifeShield

The Issue: Hospira has received reports of customers experiencing air-in-line

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

Class II — Potential Health HazardTerminated
June 17, 2013· Nanosphere, Inc.

Recalled Item: Verigene BC-GN Kit (Catalog number 20-005-021)

The Issue: There is a specific Extraction Tray lot containing

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

Class II — Potential Health HazardTerminated
June 17, 2013· Nanosphere, Inc.

Recalled Item: Verigene BC-GP Kit (Catalog number 20-005-018)

The Issue: There is a specific Extraction Tray lot containing

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

Class II — Potential Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· CareFusion 303, Inc.

Recalled Item: Alaris PC unit

The Issue: CareFusion is recalling the Alaris PC units model

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: Albo Graft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Woven with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated
June 17, 2013· LeMaitre Vascular, Inc.

Recalled Item: AlboGraft Knitted with Collagen

The Issue: Blood blushing/leaking from the surface of the graft

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

Class I — Serious Health HazardTerminated