# FDA recall Z-0036-2025

> **Wilson-Cook Medical Inc.** · Class II · device recall initiated 2024-08-29.

## Product

Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.

## Reason for recall

Specific lots of product have been manufactured with nonconforming raw materials.

## Distribution

Distribution was nationwide.  There was government and military distribution.  Foreign distribution was made to Canada, Costa Rica, and Guatemala.  UPDATE 1/30/2025:  Foreign distribution was made to:  Australia, Austria, Belgium, Canada, Chile, Costa Rica, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Italy, Latvia, Luxembourg, Mexico, Myanmar, Netherlands, Norway, New Zealand, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

## Key facts

- **Recall number:** Z-0036-2025
- **Recalling firm:** Wilson-Cook Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-29
- **Report date:** 2024-10-23

- **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-0036-2025

## Citation

> AI Analytics. FDA recall Z-0036-2025. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0036-2025. Source: US FDA. Licensed CC0.

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