# FDA recall Z-0582-2025

> **Wilson-Cook Medical Inc.** · Class II · device recall initiated 2024-10-31.

## Product

Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.

## Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation knob internal threading while the device is activated.

## Distribution

Distribution was OUS only to Argentina, Brazil, and Israel.

## Key facts

- **Recall number:** Z-0582-2025
- **Recalling firm:** Wilson-Cook Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-31
- **Report date:** 2024-12-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winston Salem, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2025

## Citation

> AI Analytics. FDA recall Z-0582-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0582-2025. Source: US FDA. Licensed CC0.

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