# FDA recall Z-0184-2026

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

## Product

Medical convenience kits     Item Number/Description  ANSH14AF	SHOULDER PACK - 205962  EVAH76H	ANTERIOR HIP PACK  FDSA15M	SHOULDER ARTHROSCOPY  GRTS90G	TOTAL SHPULDER PACK   HGHI26G	HIP PINNING PACK  HJTO25C	TOTAL HIP ACCESSORY PACK  HNEX60L	EXTREMITY PACK  IAHD53C	HAND PACK  IASH65A	SHOULDER PACK  IHUE40AI	UPPER EXTREMITY PK| STRL F G  ILTJ47AA	TOTAL JOINT PACK  LMHP14Z	ORIF HIP, ST LUKES METHODIS  LMSN44AE	SPINAL PACK  MHHP25H	HAND PACK - 206002  MHTH90AJ	TOTAL HIP PACK - 206016  MWAH32P	ANTERIOR HIP PACK  MWTK13AH	TOTAL KNEE  PLOR89H	ORTHO MINOR PACK  RCUE81B	UPPER EXTREMITY RCH 0247031  TSTH54D	TOTAL HIP TRAY  UDEX85Y	DSC EXTREMITY - 206050  UDHD69U	HAND PACK - 206055  UDKN68AH	CUSTOM KNEE - 206061  UIHN18AW	ACS HAND PACK (PS 020640)  UIHN18AX	ACS HAND PACK (PS 020640)  UIKN28AR	ASC KNEE PACK (PS 020641)  UISO44I	SFCH SMALL ORTHO PACK (PS 143213)

## 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-0184-2026
- **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-0184-2026

## Citation

> AI Analytics. FDA recall Z-0184-2026. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-0184-2026. Source: US FDA. Licensed CC0.

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