# FDA recall Z-0171-2026

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

## Product

Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571)

## 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-0171-2026
- **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-0171-2026

## Citation

> AI Analytics. FDA recall Z-0171-2026. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-0171-2026. Source: US FDA. Licensed CC0.

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