# FDA recall Z-1406-2025

> **American Contract Systems Inc** · Class II · device recall initiated 2025-02-04.

## Product

CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.

## Reason for recall

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

## Distribution

US: MI

## Key facts

- **Recall number:** Z-1406-2025
- **Recalling firm:** American Contract Systems Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-04
- **Report date:** 2025-03-26

- **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-1406-2025

## Citation

> AI Analytics. FDA recall Z-1406-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1406-2025. Source: US FDA. Licensed CC0.

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