ICU Medical recall: CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes…
ICU Medical, Inc. is recalling CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes… – 185,688 units. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on August 20, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

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| Product | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes… |
| Brand | ICU Medical |
| Company | ICU Medical, Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 20, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 185,688 units |
| Recall ID | 99648 |
Recalled 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
- FDA recall number
- Z-3212-2026
- Codes, lots and dates
- 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
- Quantity
- 185,688 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99648
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Lake Forest, IL, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99648, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other ICU Medical recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 23, 2026 | Intravascular administration tubing set drip chambers may have black specks potentially du… Serious | FDA Class II |
Other medical device recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious | FDA Class I | |
| Oct 7, 2026 | a fire hazard Most serious | FDA Class I | |
| Oct 7, 2026 | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II | |
| Oct 7, 2026 | Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious | FDA Class II | |
| Oct 7, 2026 | The potential for falsely elevated results. Serious | FDA Class II | |
| Oct 7, 2026 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is ICU Medical CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes… recalled?
Yes. ICU Medical, Inc. recalled it on August 20, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.