Product Wiki · Recalls · U.S. FDA — Device Enforcement

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/Item Number JKLC55H; 4) LAPAROSCOPY PACK, Model/Item Number LLLA21K; 5) GENERAL LAPAROSCOPY MPH, Mod — recall Z-2465-2025

U.S. FDA — Device Enforcement · United States · 2025-07-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2465-2025
Date of alert
2025-07-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
American Contract Systems Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00191072235503
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.