Device recall
Z-0655-2025: Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long…
FDA device recall · Class I · Kirwan Surgical Products, LLC
Key facts
| Recall number (Z-number) | Z-0655-2025 |
|---|---|
| Recall event | 95753 |
| Product | Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L 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… |
| 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