ICU Medical 31" — Class II medical device recall Z-0359-2026
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-0359-2026 |
|---|---|
| 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 | 11,000 units |
| Reason classes | packaging, device malfunction |
| Lot numbers | 14397353, 14418912 |
| Model numbers | CL3951 |
Product
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
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-0359-2026. 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.