FDA Device recall Z-1406-2025
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit
- FDA Device
- Class II
- ongoing
- Published 2025-03-26
On 2025-03-26 the FDA classified a Class II recall of CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit by American Contract Systems, citing during an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilizati….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1406-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-04 |
| Published | 2025-03-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | American Contract Systems |
| Distribution | MI |
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reason
During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.
Identifiers
| code_info | Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Ex…Lot Code: UDI: 191072216984, Lot Cocdes: 71-052536, Exp: 10/30/2025; 71-051491, Exp: 07/16/2025; LOT: 71-051609, Exp: 07/30/2025; 71-051767, Exp: 08/14/2025; 71-053065, Exp: 12/10/2025 |
|---|
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-1406-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.