CADD Yellow Medication Cassette Reservoir with NRFit Connector
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
ICU Medical, Inc., of Lake Forest, Illinois, recalled its CADD Yellow Medication Cassette Reservoir with NRFit connector because the reservoirs may exhibit medication leakage at the joint between luer connector and tubing. The issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus. The company began the recall on August 20, 2026, and the FDA added it to the Enforcement Report on September 17, 2026.
The recalled product was distributed worldwide, including US nationwide distribution in Arkansas, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Tennessee, Texas, Virginia and Wisconsin, and in Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden. The recall involves 185,688 units.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your cassette affected?
Compare every listed detail under your product with its label.
CADD Yellow Medication Cassette Reservoir with NRFit connector
- UDI-DI
- 30610586044001
- 30610586044018
- Product code (US)
- 21-7600-24
- 21-7609-24
- Product code (outside US)
- 21-7609-24
- 21-7600-24
- 21-7609-24JP
- 21-7600-24JP
- Lot
- 6026878
- 6037784
- 6054015
- 6062724
- 6070616
- 6082332
- 6092886
- 6101906
- 6108556
- 6126029
- 6140893
- 6143454
- 6147696
- 6147697
- 6162769
- 6155095
- 6166032
- 6171587
- 6171586
- 21-7609-24
- 6022079
- 6037697
- 6037698
- 6053978
- 6061525
- 6072970
- 6072964
- 6070575
- 6077773
- 6092846
- 6101798
- 6108514
- 6108515
- 6108516
- 6140862
- 6140861
- 6140865
- 6155132
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Arkansas, California, Florida, Illinois, Indiana, Louisiana, Michigan, Missouri, Mississippi, Tennessee, Texas, Virginia, Wisconsin and the countries of Austria, Australia, Belgium, Costa Rica, Germany, Estonia, Spain, Finland, France, Great Britain, Ireland, Italy, Japan, Kuwait, Netherlands, Norway, and Sweden.
- Event ID
- 99648
- Recall No.
- Z-3212-2026
- Company
- ICU Medical, Inc.Lake Forest, Illinois
- Hazard
- Device defect
- Quantity recalled
- 185,688 units
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
