Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended… — Class II medical device recall Z-0314-2025
Ongoing recall by Nihon Kohden America Inc, reported 2024-11-13, distributed nationwide. Due to products being shipped/distributed to customers after the products expiration date had past.
| Recall number | Z-0314-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nihon Kohden America Inc, Irvine, CA, United States |
| Recall initiated | 2022-04-29 |
| Classified | 2024-11-06 |
| Reported by FDA | 2024-11-13 |
| Distributed | Nationwide (US) |
| Quantity | 17 devices |
| UPC / GTIN / UDI-DI | 14931921904043 |
| Lot numbers | 706121CB, 706301CB, 707211CB |
| Model numbers | 14931921904043, YG-227T |
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.
Reason for recall
Due to products being shipped/distributed to customers after the products expiration date had past.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0314-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.