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 26121–26140 of 38,428 recalls

September 27, 2016· ICU Medical, Inc.

Recalled Item: Transpac¿ IV Trifurcated 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: TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 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: Monitoring Kit w/TP4

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 SALINA REGIONAL

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: Monitoring Kit w/TP4

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 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: 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: CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS 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 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: Transpac¿ IV Kit w/2 3-Way Stopcocks and 48" Pressure TBG

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 4 FT. CABLE EXTENSION AND

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 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: Cath Lab Kit w/Waste Bag

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 Monitoring Kit w/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: Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 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: CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART 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 2 SAFESET" 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: Transpac¿ IV Monitoring Kit w/ 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: PERFUSION PUMP KIT FOR MEMORIAL 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