Device recall
Z-2484-2025: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The…
FDA device recall · Class I · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2484-2025 |
|---|---|
| Recall event | 97303 |
| Product | ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the… |
| Product code | KTI |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K193517 |
| FEI number | 2429304 |
At a glance
- 1–9 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