Wilson-Cook Medical Inc.: Device Recall
Recall #Z-0582-2025 · 10/31/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0582-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Wilson-Cook Medical Inc.
- Status
- Ongoing
- Date Initiated
- 10/31/2024
- Location
- Winston Salem, NC, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 46 devices
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.
Product Description
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Distribution Pattern
Distribution was OUS only to Argentina, Brazil, and Israel.
Other Recalls by Wilson-Cook Medical Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 08/29/2024
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.