Device recall
Z-0314-2025: Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample…
FDA device recall · Class II · Nihon Kohden America Inc
Key facts
| Recall number (Z-number) | Z-0314-2025 |
|---|---|
| Recall event | 95480 |
| Product | Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only. |
| Product code | CCK |
| Recalling firm | Nihon Kohden America Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K171765 |
| FEI number | 2080783 |
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