FDA-Device2026-09-23Class IIPROCESSING DEFECT
ICU Medical CADD Yellow Medication Cassette Reservoir recalled for medication leakage risk
What this means
ICU Medical's CADD Yellow Medication Cassette Reservoirs may leak medication at the connection point between the luer connector and tubing. This leakage could delay or stop medication delivery, reduce the amount of medication received, expose patients to contamination, or allow air to enter the bloodstream.
- Check if you have a CADD Yellow cassette with product codes 21-7600-24 or 21-7609-24
- Contact ICU Medical or your healthcare provider if you have an affected cassette
- Do not use the cassette if you notice any leakage or connection issues
- Ask your provider about replacement options while you wait for a corrected device
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
185,688 units
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3212-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical IV Sets with drip chambers recalled for black specks in fluid path
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV gravity administration sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical Plum administration sets recalled for black specks in drip chambers
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