← FDA ENFORCEMENT
Z-3212-2026Class II

ICU Medical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
ICU Medical, Inc.
Product type
Device
Status
Ongoing
Report date
2026-09-23
Distribution
Worldwide - US Nationwide distribution in the states of AR, CA, FL, IL, IN, LA, MI, MO, MS, TN, TX, VA, WI and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.
Firm state
IL
Product quantity
185,688 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

Product description

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24

Code / lot info

21-7600-24 UDI-DI 30610586044001 Lots 6026878 6037784 6054015 6062724 6070616 6082332 6092886 6101906 6108556 6126029 6140893 6143454 6147696 6147697 6162769 6155095 6166032 6171587 6171586 21-7609-24 UDI-DI 30610586044018 Lot 6022079 6037697 6037698 6053978 6061525 6072970 6072964 6070575 6077773 6092846 6101798 6108514 6108515 6108516 6140862 6140861 6140865 6155132

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →