Class II — Nihon Kohden America Inc
| Recalling firm | NIHON KOHDEN CORP. |
|---|---|
| Registered facility | View this company's 11 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to products being shipped/distributed to customers after the products expiration date had past. |
| 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. |
| Quantity | 17 devices |
| Distribution | U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT. |
| Initiated | 2022-04-29 |
| Classified | 2024-11-06 |
| Recall number | Z-0314-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nihon Kohden America Inc (Z-0314-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95480/
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