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 1261–1280 of 38,428 recalls

September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Graduated Connector w/ChemoLock Port

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Clave Bag Spike w/ChemoLock Port

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock Port

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Oncology Kit w/2 ChemoLock"

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Double ChemoLock Port Syringe Transfer Set

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemosafeLock Bag Spike

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 45" (114 cm) Appx 1.7 ml

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock Bag Spike

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Oncology Kit w/ChemoLock

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock Closed Vial Spike

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 31" (79 cm) Appx 3.4 ml

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock 13mm Closed Vial Spike

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 73" (185 cm) Appx 2.5 ml

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock w/Mini Bag Spike ¿

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical 7.5" (19 cm) Appx 1.5 ml

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock Bag Spike with Clave Additive Port

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
September 8, 2025· ICU Medical, Inc.

Recalled Item: ICU Medical ChemoLock Vented Vial Spike

The Issue: Port weld of drug transfer device may separate

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing