# FDA recall Z-0175-2026

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

## Product

Medical convenience kits     Item Number/Description  EVLH67F	LEFT HEART CATH PACK  FDCL22R	CATH LAB ANGIO  IHCC03X	CATH CARDIAC PACK  TNCC02AD	CARDIAC CATH TRINITY  UICC27AG	CARDIAC CATH ANGIO PACK (PS 923077)  UIRD89AH	RADIAL PACK (PS 56573)

## 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-0175-2026
- **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-0175-2026

## Citation

> AI Analytics. FDA recall Z-0175-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0175-2026. Source: US FDA. Licensed CC0.

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