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 26461–26480 of 38,428 recalls

August 10, 2016· ICU Medical, Inc.

Recalled Item: Monitoring Kit with 30mL 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Monitoring Kit with SafeSet 84inch 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Monitoring Kit with 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
August 10, 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
August 10, 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Monitoring Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Trifurcated 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Pediatric Kit with 30mL 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: SafeSet Kit with 30 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: 5 Port OFF Manifold with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Monitoring Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Monitoring Kit with 2 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Bifurcated Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Monitoring Kit with 03 ml Squeeze Flush

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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Monitoring Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Trifurcated Monitoring Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Bifurcated SafeSet Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Triple Line SafeSet Kit with 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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2

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
August 10, 2016· ICU Medical, Inc.

Recalled Item: Transpac IV Trifurcated Monitoring Kit with 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