Cordis — Class II medical device recall Z-1510-2025
Ongoing recall by Cordis US Corp, reported 2025-04-09, distributed in AR, AZ, FL, NJ, TN. product mix-up; Vascular stent labeled as one size but contains a different size.
| Recall number | Z-1510-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis US Corp, Miami Lakes, FL, United States |
| Recall initiated | 2025-03-04 |
| Classified | 2025-04-03 |
| Reported by FDA | 2025-04-09 |
| Distributed | AR, AZ, FL, NJ, TN |
| Countries outside the US | JP |
| Quantity | 20 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 20705032024591 |
| Lot numbers | 18298569 |
| Model numbers | C10040ML |
Product
Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only
Reason for recall
product mix-up; Vascular stent labeled as one size but contains a different size.
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-1510-2025. 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.