Recall archive / FDA device enforcement
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. — FDA record Z-0582-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 31, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- 46 devices
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0582-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI 00827002246638, Lot numbers W4844245, exp. 6/10/2027; W4847501, exp. 6/20/2027; and W4851589, exp. 7/8/2027. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was OUS only to Argentina, Brazil, and Israel.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 11, 2024
- Recall initiation date
- Oct 31, 2024
- Center classification date
- Dec 2, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.