Device recall
Z-1884-2025: Male-Female Midsection with the following sizes and model numbers. a…
FDA device recall · Class II · Onkos Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1884-2025 |
|---|---|
| Recall event | 96782 |
| Product | Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1… |
| Product code | KRO |
| Recalling firm | Onkos Surgical, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161520 |
| FEI number | 3013450937 |
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