IV Administration sets — Class I medical device recall Z-0154-2026
Ongoing recall by ICU Medical, Inc., reported 2025-10-29, distributed nationwide. IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop
| Recall number | Z-0154-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., San Clemente, CA, United States |
| Recall initiated | 2025-10-02 |
| Classified | 2025-10-23 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Quantity | 23,203 |
| UPC / GTIN / UDI-DI | 10840619005068, 10840619045859, 10887709007823, 10887709015033, 10887709015040 |
| Lot numbers | 14065820, 14110075, 14126963, 14129823, 14211300, B33359/10887709007823/14070544, B9213/10840619045859/14130197, B9732/10887709015033/14149636, B9733/10887709015040/14176779 |
| Model numbers | 011-C7014, B33359, B9213, B9732, B9733 |
Product
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
Reason for recall
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
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-0154-2026. 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.