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 13621–13640 of 38,428 recalls

November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select)

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select)

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated
November 24, 2020· Cook Inc.

Recalled Item: Flexor Check-Flo Introducer

The Issue: There is an increased likelihood of the introducer

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

Class I — Serious Health HazardTerminated