# FDA recall Z-0176-2026

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

## Product

Medical convenience kits     Item Number/Description  ANCV78BC	HEART PACK - 205947  HGCV05K	CV SET UP PACK  MHPP97AR	PACEMAKER PACK- 206010  UDBH37AW	BASIC HEART PACK - 206044  UHPP82AH	PERIPHERAL PACK - 209533  UICD62AN	CARDIOVASCUALR SUPPLY (PS 907285)  UICT16F	 CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I	VASCULAR 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-0176-2026
- **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-0176-2026

## Citation

> AI Analytics. FDA recall Z-0176-2026. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-0176-2026. Source: US FDA. Licensed CC0.

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