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 19641–19660 of 38,428 recalls

September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 4mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 5mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 12mm x 40mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 12mm x 40mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 5mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 4mm x 60mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 5mm x 20mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 12mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 5mm x 40mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 4mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 14mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 12mm x 30mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 12mm x 60mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 14mm x 60mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 5mm x 60mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver Biliary 518 Stent 5mm x 60mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 518 Biliary Stent 4mm x 30mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 5mm x 40mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 4mm x 80mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated
September 25, 2018· Cook Medical Incorporated

Recalled Item: Zilver 635 Biliary Stent 5mm x 40mm

The Issue: The instruction for use detail, with respect to

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

Class II — Potential Health HazardTerminated