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 15261–15280 of 38,428 recalls

April 13, 2020· American Contract Systems

Recalled Item: Sterile Custom Packs to be used in surgical procedures.

The Issue: The surgical gowns were manufactured in a facility

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

Class II — Potential Health HazardTerminated
April 13, 2020· Philips North America, LLC

Recalled Item: Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product...

The Issue: The rotary therapy selector switch may fail, resulting

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated
April 13, 2020· K2M, Inc

Recalled Item: K2M

The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured

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

Class II — Potential Health HazardTerminated