ICU Medical, Inc. CADD Yellow Medication Cassette Reservoir with NRFit connector US recall: Reservoirs may exhibit medication leakage at the joint between luer connector
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.
The hazard: Harmful chemical exposure
The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.
What the notice says: 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.
Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.
Symptoms and when to call a doctor
For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.
This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.
Recall details
- Recall number
- Z-3212-2026
- Published
- September 23, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 185,688 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code 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
- UPC codes
- 30610586044001, 30610586044018
Products covered by this recall
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
Check your product
The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 30610586044001
- 30610586044018
Model or item number
On the rating label, the box or the instruction sheet.
- 21-7600-24
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Chemical
ICU Medical, Inc. — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.
- Stop using the product and keep it away from children and pets.
- If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
- Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.
- Ventilate the room if the product was sprayed or applied there.
If the claim stalls
Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.
- Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
- If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
- Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.
- Send the photos they asked for in the format they asked for. A missing date code is the single commonest reason a claim sits unprocessed.
Company contact: ICU Medical, Inc. — 600 N Field Dr, Lake Forest, IL, 60045-4835
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical, Inc. medical devices 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. 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.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 30610586044001, 30610586044018; model number 21-7600-24. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Stop using the product and keep it away from children and pets.
Can I get my money back?
Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
Where was the recalled product sold?
It was distributed nationwide.
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