# FDA recall Z-0180-2026

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

## Product

Medical convenience kits     Item Number/Description  HSAN63N	ANGIO PACK  IHAN02W	ANGIOGRAPHY PACK  MHCA98AK	CORONARY ANGIO PACK- 205991  RCAN45C	ANGIO CUSTOM RCH  UDCO10F	CVL CORONARY PACK   219224

## 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-0180-2026
- **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-0180-2026

## Citation

> AI Analytics. FDA recall Z-0180-2026. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/Z-0180-2026. Source: US FDA. Licensed CC0.

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