# FDA recall Z-0185-2026

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

## Product

Medical convenience kits     Item Number/Description  BFCT04X	CATARACT PACK - 205986  CMEY17AI	EYE PACK - 213187  CMEY17AI	EYE PACK - 213187  CMEY17AI	EYE PACK - 213187  PERP25AQ	PEI RETINAL PACK-206025  RFEY50AC	EYE PACK-206026  UIVT47AS	VITRECTOMY SUPPLY

## 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-0185-2026
- **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-0185-2026

## Citation

> AI Analytics. FDA recall Z-0185-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0185-2026. Source: US FDA. Licensed CC0.

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