Device recall
Z-2139-2025: Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The…
FDA device recall · Class II · Olympus Corporation of the Americas
Key facts
| Recall number (Z-number) | Z-2139-2025 |
|---|---|
| Recall event | 96982 |
| Product | Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during… |
| Product code | HIH |
| Recalling firm | Olympus Corporation of the Americas |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K890328 |
| 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