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 14821–14840 of 38,428 recalls

June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Male Luer Connectors

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Filter

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Filter

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: CMExpress Microbore Set

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: CMExpress Microbore Set

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset with Needleless Adaptor

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: CMExpress Needleless Y Site Microbore Set

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: BodyGuard Microset

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated
June 16, 2020· CME America, LLC

Recalled Item: CMExpress Microbore Set

The Issue: Infusion administration sets may have a delivery inaccuracy

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

Class I — Serious Health HazardTerminated