Device recall
Z-1736-2025: Introducer Needle REF NDL-107-04 These needles are used for the percutaneous…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-1736-2025 |
|---|---|
| Recall event | 96622 |
| Product | Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires |
| Product code | DWS |
| Recalling firm | Galt Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3000718472 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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