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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

98

Past Year

47

Class I (Serious)

2

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 1–20 of 98 recalls

LifeShield Drug Library Management (DLM), LifeShield Infu... (ICU Medical, Inc.) – software issue only allows concentrat... (2025)

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.

FDANov 24, 2025Nationwide• ICU Medical, Inc.

LifeShield Drug Library Management (DLM); LifeShield Infu... (ICU Medical, Inc.) – for certain customers, the change sum... (2025)

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.

FDANov 24, 2025Nationwide• ICU Medical, Inc.

IV Administration Set (ICU Medical) – missing shutoff valve (2025)

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IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.

Moderate

FDAOct 2, 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.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Oncology Transfer 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.

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.

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.

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.

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.

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.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Mini 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.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

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.

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.

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.

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.

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.

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.

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.

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.

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.

FDASep 8, 2025Nationwide• ICU Medical, Inc.