# FDA recall Z-0754-2025

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2024-11-12.

## Product

STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695

## Reason for recall

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0754-2025
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-12
- **Report date:** 2025-01-01

- **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-0754-2025

## Citation

> AI Analytics. FDA recall Z-0754-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0754-2025. Source: US FDA. Licensed CC0.

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