iCast Covered Stent — Class II medical device recall Z-0024-2025
Ongoing recall by Atrium Medical Corporation, reported 2024-10-16, distributed nationwide. There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
| Recall number | Z-0024-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Atrium Medical Corporation, Merrimack, NH, United States |
| Recall initiated | 2024-09-09 |
| Classified | 2024-10-07 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Quantity | 11 devices |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00650862426168 |
| Lot numbers | 508083 |
| Serial numbers | 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042 |
| Model numbers | 42616 |
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reason for recall
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
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-0024-2025. 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.