# FDA recall Z-0174-2026

> **American Contract Systems Inc.** · Class II · device recall initiated 2025-09-04.

## Product

Medical convenience kits     Item Number/Description  BUCY78E	CYSTO PACK  CMCP10X	CYSTO PACK - 205972  IHCY10Y	CYSTO PACK  MHCY35AE	CYSTO PACK- 212487  PLBY52E	CYSTO PACK  UDCY31Z	CYSTO PACK - 206047  UICY28L	MOR CYSTO PACK

## Reason for recall

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

## Distribution

US Nationwide distribution in the states of SD, IA, MN, WA, IL.

## Key facts

- **Recall number:** Z-0174-2026
- **Recalling firm:** American Contract Systems Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-04
- **Report date:** 2025-10-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grimes, IA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2026

## Citation

> AI Analytics. FDA recall Z-0174-2026. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0174-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*