# FDA recall Z-2466-2025

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

## Product

AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as:    1) 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.

## Distribution

US distribution to states of:  IL and LA

## Key facts

- **Recall number:** Z-2466-2025
- **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-2466-2025

## Citation

> AI Analytics. FDA recall Z-2466-2025. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-2466-2025. Source: US FDA. Licensed CC0.

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