Use caution Medical device recall · FDA · Published March 24, 2026

ICU Medical Oncology Kit Recall: Leaks May Cause Therapy Interruption

ICU Medical recalls oncology kits with potential leaks during chemotherapy that could interrupt treatment and expose patients to hazardous substances. Affected kits include specific models and lots; contact for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2210-2026Medical device ICU Medical ›

Use caution until it’s fixed

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

Take action

Contact the company

Recalling firmICU Medical, Inc.951 Calle Amanecer · San Clemente, CA 92673-6212

✎ GovInfoNow plain-language explainer

ICU Medical is recalling certain oncology kits that may leak during chemotherapy. If leaks occur during treatment, patients might get less medication than intended, and hazardous substances could be exposed to them or caregivers. Read more at govinfonow.com/recall/49640-icu-medical-oncology-kit-recall-leaks-may-cause-therapy-interruption.

Source Summary by GovInfoNow · govinfonow.com/recall/49640-icu-medical-oncology-kit-recall-leaks-may-cause-therapy-interruption · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2210-2026

Cite this page

“ICU Medical Oncology Kit Recall: Leaks May Cause Therapy Interruption.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49640-icu-medical-oncology-kit-recall-leaks-may-cause-therapy-interruption. Based on FDA recall #Z-2210-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2210-2026%22&limit=1).

The FDA announced on March 24, 2026, that ICU Medical, Inc. is recalling Oncology Kits due to potential leakage hazards. The agency issued recall number Z-2210-2026 for the voluntary Class II action affecting approximately 20,506 units distributed nationwide.

How to tell if you have it

Brand: ICU Medical
Product: Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port
REF: CL3960
UDI-DI: 10887709083278
Lots: 13919794, 14134777, 14196319

The hazard

According to the FDA, the oncology sets and closed system transfer devices with extension sets may leak. This leakage can result in therapy interruption if it occurs during treatment, potentially causing patients to receive less infusion solution than intended. Exposure of hazardous substances to patients, caregivers, or pharmacy technicians is also possible.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls include the August 20, 2026 ICU Medical CADD Yellow Medication Cassette Reservoir Recall for leakage risk and the June 24, 2026 ICU Medical Hotline Fluid Warming Set Recall for leakage in specific lots. Similar product recalls include the June 12, 2026 Medline Convenience Kits Recall for sterile packaging breach risk, the July 10, 2026 Medline Convenience Kits Recall for contaminated components, and the March 24, 2026 Medline Medical Kits Recall for particulate risk.

How to tell if you have this one

Check for the model name 'Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port' and lots 13919794, 14134777, or 14196319.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Leaks
Inspect the kit for leaks during setup or therapy; if leaks occur, stop treatment immediately.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 26 states.

FDA distribution: “US Nationwide distribution in the states of GA, MA, OH, NC, CA, ND, MI, TX, FL, AR, CT, PA, WA, WI, CO, VT, NY, NH, KY, IA, KS, AL, NM, IL, MO, NJ.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Massachusetts, Michigan, Missouri, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Texas, Vermont, Washington, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 24, 2026Firm started the recall
May 18, 2026FDA classified it Class II
May 27, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/49640-icu-medical-oncology-kit-recall-leaks-may-cause-therapy-interruption">ICU Medical Oncology Kit Recall: Leaks May Cause Therapy Interruption (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2210-2026 (March 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2210-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.