Device recall
Z-0036-2025: Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile…
FDA device recall · Class II · Wilson-Cook Medical Inc.
Key facts
| Recall number (Z-number) | Z-0036-2025 |
|---|---|
| Recall event | 95300 |
| 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. |
| Product code | QAU |
| Recalling firm | Wilson-Cook Medical Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200972 |
| FEI number | 1037905 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database