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 26201–26220 of 38,428 recalls

September 27, 2016· ICU Medical, Inc.

Recalled Item: ART/CVP KIT W/03ML FLUSH DEVICE FOR MILWAUKEE 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 W/03ML FLUSH DEVICE FOR NE REGIONAL 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: Cath Lab Kit For Elkhart 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 DISPOSABLE TRANSDUCER WITH STOPCOCKS

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¿ w/Safeset Reservoir

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 WITH DISPOSABLE TRANSDUCER

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 WITH 03ML FLUSH DEVICE FOR CARLE CLINIC

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/Arterial 84" Safeset" Reservoir

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 PRESSURE KIT W/03ML FLUSH DEVICE 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: TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH

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 BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS

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: LEFT HEART KIT FOR PORTLAND ADVENTIST 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: TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT

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/Waste Bag System

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 84" Arterial 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: ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV. 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: CARDIAC KIT WITH 03 ml FLUSH DEVICE

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/4 Way Stopcock

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