CRANI PACK — Class II medical device recall Z-1406-2025
Ongoing recall by American Contract Systems Inc, reported 2025-03-26. During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required St
| Recall number | Z-1406-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Contract Systems Inc, Tiffin, OH, United States |
| Recall initiated | 2025-02-04 |
| Classified | 2025-03-20 |
| Reported by FDA | 2025-03-26 |
| Quantity | 91 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00191072216984 |
| Lot numbers | 71-051609, 71-051767, 71-053065 |
| Model numbers | WECR41D |
| Expiration dates | 2025-07-16, 2025-07-30, 2025-08-14, 2025-10-30, 2025-12-10 |
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Reason for recall
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.
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-1406-2025. 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.