# FDA recall Z-0983-2025

> **O&M HALYARD, INC.** · Class II · device recall initiated 2024-11-26.

## Product

Brand Name: HALYARD  Product Name: Laparotomy Pack  Model/Catalog Number: 88231  Software Version: N/A  Product Description: Laparotomy Pack  Component: N/A

## Reason for recall

Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

## Distribution

US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS, LA, MI, MN, MO, NC, NE, NY, TN, TX, VA, WI.

## Key facts

- **Recall number:** Z-0983-2025
- **Recalling firm:** O&M HALYARD, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-26
- **Report date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mechanicsville, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2025

## Citation

> AI Analytics. FDA recall Z-0983-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0983-2025. Source: US FDA. Licensed CC0.

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