Device recall
Z-1954-2025: Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up…
FDA device recall · Class II · Tecfen Medical
Key facts
| Recall number (Z-number) | Z-1954-2025 |
|---|---|
| Recall event | 96872 |
| Product | Brand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel Up Model/Catalog Number: QKN1010 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile and packaged individually in Tyhvek 1059B. The crescent knife is used to create… |
| Product code | HNN |
| Recalling firm | Tecfen Medical |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3010487482 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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