Device recall
Z-2344-2025: OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses…
FDA device recall · Class II · LUMENIS, LTD.
Key facts
| Recall number (Z-number) | Z-2344-2025 |
|---|---|
| Recall event | 97279 |
| Product | OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue. |
| Product code | GEX |
| Recalling firm | LUMENIS, LTD. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K130164 |
| FEI number | 3004135191 |
At a glance
- 1–9 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