# FDA recall Z-0175-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-09-04.

## Product

Medline brand medical procedure convenience kits, labeled as:    a) LITHOTOMY PACK, REF DYNJ24362C;   b) MAJOR GYNE LAPAROSCOPY SHSC, REF DYNJ46774B;   c) GYN ANCILARY PACK, REF DYNJ84509;   d) GYN LITHOTOMY MINOR, REF DYNJ907707

## Reason for recall

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama.

## Key facts

- **Recall number:** Z-0175-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-04
- **Report date:** 2024-10-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0175-2025

## Citation

> AI Analytics. FDA recall Z-0175-2025. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0175-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*