# FDA recall Z-0183-2026

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

## Product

Medical convenience kits     Item Number/Description  HSLM53AB	SPINE PACK  MILM82A	DTC LAMINECTOMY PACK (PS 209475)  RCNA47B	NEURO ANGIO 0246971  SFLM54AB	LAMINECTOMY PACK - 219659  UDLM94AA	LAMINECTOMY PACK - 206064  UILM77AU	LAMINECTOMY (PS 039500)  UINR44P	NEURO IR PERIPHERAL (PS 64405)  UISH15AV	SHUNT PACK (PS 039360)

## 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-0183-2026
- **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-0183-2026

## Citation

> AI Analytics. FDA recall Z-0183-2026. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0183-2026. Source: US FDA. Licensed CC0.

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