FDA · Class II · September 23, 2026

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.

An FDA laboratory that tests medical devices
Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.
ProductCADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes…
BrandICU Medical
CompanyICU Medical, Inc.
TypeMedical devices
ClassificationClass II
Recall dateAugust 20, 2026
Published by FDASeptember 23, 2026
Quantity185,688 units
Recall ID99648
As listed by FDA

Recalled products

  1. 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
Exactly as the agency lists them

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.

Same brand

Other ICU Medical recalls

DateRecallProblemAgency
Sep 23, 2026ICU Medical recall: Plum administration sets and 3 more productsMedical devices · 163,500,199; 2,450; 107,800; 28,550; 100,712,657; 6,105,468; 86,113; 56,553,672Intravascular administration tubing set drip chambers may have black specks potentially du…
Serious
FDA
Class II
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FAQ

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.

Recalls

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.

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