ICU Medical 8" — Class II medical device recall Z-0358-2026
Ongoing recall by ICU Medical, Inc., reported 2025-11-05, distributed nationwide. Port weld of drug transfer device may separate or break during use and potentially result in a leak.
| Recall number | Z-0358-2026 |
|---|---|
| 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 | 2025-09-08 |
| Classified | 2025-10-27 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR, JP |
| Quantity | 2,450 units |
| Reason classes | packaging, device malfunction |
| Lot numbers | 14393168, 14414091 |
| Model numbers | CL-3950 |
Product
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Reason for recall
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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-0358-2026. 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.