Device recall
Z-0660-2025: Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011…
FDA device recall · Class I · Kirwan Surgical Products, LLC
Key facts
| Recall number (Z-number) | Z-0660-2025 |
|---|---|
| Recall event | 95753 |
| Product | Optikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product Description: The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, and other soft tissue procedures. For instance, the pencils are designed for cauterization of the retinal area during… |
| Product code | GEI |
| Recalling firm | Kirwan Surgical Products, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K864402 |
| FEI number | 1219619 |
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