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 26101–26120 of 38,428 recalls

September 27, 2016· ICU Medical, Inc.

Recalled Item: TRANSPAC¿ IV MONITORING KIT 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: Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.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: QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART 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 DISPOSABLE TRANSDUCER WITH BONDED 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
September 27, 2016· ICU Medical, Inc.

Recalled Item: Cath Lab Kit W/30ML Flush Device for Monongalia General 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 Transpac¿ IV w/03 ml Squeeze 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: Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze 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: Cath Lab Kit w/3 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: DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET

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 ARTERIAL 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: CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE

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 NYU 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: 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: Cardiac Catheterization Right Heart Kit w/2-Station

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: 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT

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 GENESIS HEALTH CARE

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 Trifurcated Monitoring Kit 84" w/03 ml Squeeze 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: CATH LAB KIT W/3 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: CATH LAB KIT #3 FOR MARY HITCHCOCK 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: Right Heart Cath Lab Kit w/2 Port "OFF" 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