Wilson-Cook Medical Inc.: Device Recall

Recall #Z-0036-2025 · 08/29/2024

Class II: Risk

Recall Details

Recall Number: Z-0036-2025
Classification: Class II
Product Type: Device
Recalling Firm: Wilson-Cook Medical Inc.
Status: Ongoing
Date Initiated: 08/29/2024
Location: Winston Salem, NC, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: UPDATE-4,605 devices

Reason for Recall

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

Product Description

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.

Distribution Pattern

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.

Other Recalls by Wilson-Cook Medical Inc.

Class II: Risk 12/15/2025

Nasal feeding tube packaged without the nasal transfer tube component.
Class II: Risk 10/31/2024

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.

View all recalls by Wilson-Cook Medical Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.