ICU Medical Oncology Kit Recall for Leak Risk
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ICU Medical, Inc. is recalling 20,506 Oncology Kits (REF: CL3960) due to potential leaks that may interrupt therapy or expose hazardous substances.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
ICU Medical, Inc. initiated a voluntary recall of certain oncology sets/closed system transfer devices because they may leak. This could result in therapy delay if noticed during setup or therapy interruption if the leak occurs during use, with potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is also possible.
Which Products Are Affected
The affected product is 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. A total of 20,506 units were distributed to US Nationwide locations including 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, and NJ.
What You Should Do
Check inventory for the listed lots and contact ICU Medical, Inc. regarding returns or further instructions.
Why This Matters
Leaks in these devices carry the risk of therapy interruption or unintended exposure to hazardous substances during oncology treatment.
Source
FDA Recall Number Z-2210-2026. Class II recall. Report date: 20260527.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,301 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.