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ICU Medical, Inc.

ICU Medical, Inc. Recalls

All product recalls associated with ICU Medical, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 98 recalls

ICU Medical Double ChemoLock Syringe Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ChemoLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Syringe Transfer Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide

123 4 5

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• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Oncology Kit (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Port (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Graduated Connector (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Admin Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemosafeLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Chemo Lock Vial Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

CADD Medication Cassette (ICU Medical) – bag weld weakness (2025)

Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.

Moderate

FDAAug 6, 2025Nationwide• ICU Medical Inc.

CADD Medication Cassette (ICU Medical) – bag weld issue (2025)

Moderate

FDAAug 6, 2025Nationwide• ICU Medical Inc.

NRFit CADD Medication Cassette (ICU Medical) – bag weld issue (2025)

Moderate

FDAAug 6, 2025Nationwide• ICU Medical Inc.