# FDA recall Z-0172-2026

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

## Product

Medical convenience kits     Item number/ Product description  AKGN82E	GENERAL  AMCB08Y	CHEST BREAST PACK  ANBP10AC	BASIC PACK - 205939  ANIR77AM	INTERVENTIONAL RADIOLOGY PACK - 205953  CFLA39G	LAPAROTOMY PACK  CIBL33I	BASIC LAP PACK  EVMN24E	MINOR ESC  EVST48E	STARTER  FDTA11AA	T & A PACK  FHHY25P	HYSTEROSCOPY PACK  HGML99G	MAJOR LAP PACK  HGXR41H	X-RAY PACK  HISU54M	SET-UP PACK  IHAA19AP	PK A A A  IHMP89K	MINOR PROCEDURE PACK  IHPD14AM	PK PEDIATRIC  LKVG10O	VAG DELIVERY  LMAG20G	VASCULAR PACK  LMLE46AA	EXTREMITY LOWER PK  MIEN58A	DTC GENERAL ENDOSCOPY PACK(PS 209468)  NUMB04H	MAJOR BASIN SET 314666  OWBS11U	BASIN SET - 206021  RCMS71B	MIS SPECIALTY RCH  SFMB55X	MINOR BASIN - 208293  STBA09F	BASIN SET   TNBS21O	BASIN SET 612833  UDBH37AX	BASIC HEART PACK - 206044  UDMA50X	MINOR ADULT - 206067  UICR54W	ACS CRS PACK (PS055042)  UIPC89D	PROCUREMENT PACK  UIPT13F	PITCHER (PS 907953)  UISB96AB	SMALL BACK TABLE SETUP (PS 907419)

## 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-0172-2026
- **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-0172-2026

## Citation

> MORVS. FDA recall Z-0172-2026. Retrieved 2026-11-02 from https://api.morvs.ai/recall/Z-0172-2026. Source: US FDA. Licensed CC0.

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