AMERICAN CONTRACT SYSTEMS — Class II medical device recall Z-2467-2025
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-2467-2025 |
|---|---|
| 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 | 6,617 units |
| UPC / GTIN / UDI-DI | 00191072003706, 00191072005571, 00191072005588, 00191072012098, 00191072103420, 00191072137111, 00191072203021, 00191072205742, 00191072222596, 00191072228512, 00191072233806, 00191072235176, 00191072235275, 00191072235541, 00191072235589, 00191072237262 |
| Lot numbers | 42-7789611, 42-7849111, 42-7867111, 42-7867811, 42-7875311, 42-7883711, 42-7905711, 42-7916611, 42-7925811, 42-7937911, 42-7940911, 42-7947511, 42-7947711, 42-7959411, 42-7980811, 42-7981511, 42-7984111, 42-8005111, 42-8007611, 42-8024111, 42-8024311, 42-8032411, 42-8047711, 42-8052111, 42-8067111, 42-8074911, 42-8095211, 42-8104211, 42-8113911, 42-8125311, 42-8134111, 5436824, 5436860, 5437058, 5437174, 5437197, 5437211, 5437326, 5437390, 5437696 and 20 more |
| Model numbers | ANCV67X, ANKP15AD, FYLA38G, HSCY13M, HSDR10K, HSMD20H, PDSA12D, SWPD12K, UDAA63AH, UDBC35AF, UDBH37AX, UIFF72AD, UIPC89D, UITR45W, UMTR17B, UMTR17C |
Product
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD; 3) LAPCHOLAPPY PACK, Model/Item Number FYLA38G; 4) CYSTO PACK, Model/Item Number HSCY13M; 5) PICC DRESSING CHANGE KIT, Model/Item Number HSDR10K; 6) MIDLINE CHANGE KIT, Model/Item Number HSMD20H; 7) SHOULDER ARTHOSCOPY PACK, Model/Item Number PDSA12D; 8) PDA LF SJW, Model/Item Number SWPD12K; 9) AAA PACK - 206038, Model/Item Number UDAA63AH; 10) BASIC CAB PACK - 206043, Model/Item Number UDBC35AF; 11) BASIC HEART PACK - 206044, Model/Item Number UDBH37AX; 12) FREE FLAP DRAPE PACK (PS 907864), Model/Item Number UIFF72AD; 13) PROCUREMENT PACK, Model/Item Number UIPC89D; 14) THYROID PACK (PS 096552), Model/Item Number UITR45W; 15) TRAUMA PACK 175634, Model/Item Number UMTR17B; 16) TRAUMA PACK 175634, Model/Item Number UMTR17C.
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-2467-2025. 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.