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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

248

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 241–248 of 248 recalls

ICU Medical, Inc.: Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, ...

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

ICU Medical, Inc.: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Rese...

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class IIModerate

FDAJul 18, 2014OR• ICU Medical, Inc.

ICU Medical, Inc.: Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoi...

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

Class II

1...11 1213

Page 13 of 13Next

Moderate

FDAJul 18, 2014OR• ICU Medical, Inc.

ICU Medical, Inc.: Hospira Intralock Lipid Compatible 3-Way Stopcock, Item N...

Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

FDAJun 11, 2008Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: ICU Medical, Inc. Cath Lab Kit W/3Port "ON" Manifold, Was...

Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

FDAJun 11, 2008Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Hospira Left Heart Kit for Southwestern M.C. , Item Numbe...

Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

FDAJun 11, 2008Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Hospira Monitoring Kit (PA Line) with 03ml Flush Device f...

Improper orientation of the stopcock handle questions whether there is an adequate gas path to assure sterility, which presents a possible compromise of sterility.

FDAJun 11, 2008Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Orbit 90 Subcutaneous Infusion Set, 9 mm Catheter, 42" Tu...

The product contains a female luer which has been reported to crack in use allowing fluid to leak from the device.

FDASep 26, 2006CA, GA, OH +2 more• ICU Medical, Inc.