Cordis ANGIOGRAPHIC CATHETERIZATION SETS — Class I medical device recall Z-0286-2024
Ongoing recall by Cordis US Corp, reported 2023-11-15. Non-sterile product labeled as sterile was distributed.
| Recall number | Z-0286-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis US Corp, Miami Lakes, FL, United States |
| Recall initiated | 2023-09-26 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Quantity | 30 devices |
| Reason classes | labeling, sterility |
| UPC / GTIN / UDI-DI | 10705032025935 |
| Lot numbers | 18223410 |
| Model numbers | CO0208 |
Product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Reason for recall
Non-sterile product labeled as sterile was distributed.
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-0286-2024. 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.