AMERICAN CONTRACT SYSTEMS — Class II medical device recall Z-2466-2025
Ongoing recall by American Contract Systems Inc, reported 2025-09-03, distributed in IL, LA. During an internal investigation, ACS determined that the rationale for sterilization of certain components wa
| Recall number | Z-2466-2025 |
|---|---|
| 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 | 2025-07-14 |
| Classified | 2025-08-28 |
| Reported by FDA | 2025-09-03 |
| Distributed | IL, LA |
| Quantity | 1,127 units |
| UPC / GTIN / UDI-DI | 00191072201621, 00191072233370, 00191072235350, 00191072235510, 00191072235527, 00191072238764 |
| Lot numbers | 12-7096811, 12-7139611, 12-7168211, 12-7191911, 12-7231611, 12-7263911, 12-7328411, 12-7370111, 12-7388611, 12-7394711, 42-7823511, 42-7832311, 42-7845011, 42-7885511, 42-7914911, 42-7962811, 42-7987311, 42-8027411, 42-8059311, 42-8106111, 42-8112211, 70-052248, 70-052954, 70-053309, 70-053805, 70-51139 |
| Model numbers | ASCY24A, BUCY78E, LMCP22T, LMTU31T, SACY80S, SPUR64F |
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T; 4) TUR BASIN PACK, Model/Item Number LMTU31T; 5) CYSTO, Model/Item Number SACY80S; 6) UROLOGY PACK, Model/Item Number SPUR64F.
Reason for recall
During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
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-2466-2025. 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.