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 23141–23160 of 38,428 recalls

July 31, 2017· ICU Medical, Inc.

Recalled Item: 121" (307 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 147" (373 cm) Bifuse Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 140" (356 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: Lopez Valve¿

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 117" (297 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 126" (320 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 135" (343 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 108" 20 Drop Blood Set w/200 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 185 cm (73") Blood Set w/200 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 85" (216 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 80" (203 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 137" (348 cm) Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 175" (445 cm) Y-Type Blood Set w/170 Micron Blood Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 125" (318 cm) Bifuse Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 98" (249 cm) Y-Type Admin Set w/170 Micron Blood Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 84" Y-Type Blood Set w/170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 128" (325 cm) Y-Type Blood Set with 170 Micron Filter

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated
July 31, 2017· ICU Medical, Inc.

Recalled Item: 32" (81 cm) Appx 4.4 mL

The Issue: Some devices were labeled as Does not contain

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

Class II — Potential Health HazardTerminated