# FDA recall Z-2465-2025

> **American Contract Systems Inc** · Class II · device recall initiated 2025-07-14.

## Product

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, Model/Item Number MPGL15G;

## 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.

## Distribution

US distribution to states of:  IL and LA

## Key facts

- **Recall number:** Z-2465-2025
- **Recalling firm:** American Contract Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-14
- **Report date:** 2025-09-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tiffin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2465-2025

## Citation

> AI Analytics. FDA recall Z-2465-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2465-2025. Source: US FDA. Licensed CC0.

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