Smiths Medical CADD" Medication Cassette Reservoir with flow stop — Class II medical device recall Z-2525-2025
Ongoing recall by ICU Medical Inc., reported 2025-09-10. Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along t
| Recall number | Z-2525-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc., Minneapolis, MN, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Quantity | 211,750 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10610586027215 |
| Lot numbers | 6005583, 6005584, 6005588, 6012462, 6022021, 6022022, 6022023, 6022024, 6022025, 6022026, 6022028, 6022030, 6022031, 6022032, 6026837, 6026839, 6037765, 6037768, 6037771, 6059294, 6059295, 6059296, 6062697, 6062698, 6077779, 6085509, 6092859, 6101810 |
Product
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Reason for recall
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
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-2525-2025. 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.