FDA Device recall Z-0024-2025
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 by Atrium Medical, citing there is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0024-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-09 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reason
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Identifiers
| code_info | UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 5080…UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2025%22
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