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 26081–26100 of 38,428 recalls

September 27, 2016· ICU Medical, Inc.

Recalled Item: MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM. HOSP.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: Cath Lab Kit w/3 Port "ON" Manifold (600 psi)

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSPAC¿ IV MONITORING KIT

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSPAC¿ IV MONITORING KIT

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: PERFUSION KIT FOR UNIV. OF IOWA

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: CATH LAB KIT w/4 PORT "ON" MANIFOLD

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSPAC¿ IV MONITORING KIT

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP.

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: Transpac¿ IV Monitoring Kit

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: Cath Lab Kit w/03 ml Intraflo

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: Transpac¿ IV Monitoring Kit w/Safeset 72" Pressure Tubing

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated
September 27, 2016· ICU Medical, Inc.

Recalled Item: MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER

The Issue: ICU Medical Inc. has identified a potential for

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

Class II — Potential Health HazardTerminated