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 26181–26200 of 38,428 recalls

September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED 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: Quad Kit W/03ML 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: NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN 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 w/Stopcocks w/o Cap and Covers

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 Left Heart Kit w/3 Port Manifold "OFF" (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: 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV

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 2 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: 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV

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 CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY 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 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: 5 Port "OFF" Manifold w/TRANSPAC¿ IV

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 PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR 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 NEONATAL

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: Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children

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: PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN 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: MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA

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: 4 PORT "OFF" 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: TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL 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: TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS...

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 UNIV. OF NEW MEXICO

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