FDA Medical devices recall ·
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat recall
- Recall number
- Z-0582-2025
- Date
- (initiated October 31, 2024)
- Company / brand
- Wilson-Cook Medical Inc.
4900 Bethania Station Rd, Winston Salem, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027.
Distribution
Distribution was OUS only to Argentina, Brazil, and Israel.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0582-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.