Oncology Kit w/60" — Class II medical device recall Z-2210-2026
Ongoing recall by ICU Medical, Inc., reported 2026-05-27, distributed nationwide. Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noti
| Recall number | Z-2210-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2026-03-24 |
| Classified | 2026-05-18 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 20,506 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10887709083278 |
| Lot numbers | 13919794, 14134777, 14196319 |
| Model numbers | CL3960 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2210-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.