FDA Device recall Z-0314-2025
Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who ca…
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who ca… by Nihon Kohden America, citing due to products being shipped/distributed to customers after the products expiration date had past.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0314-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-29 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Nihon Kohden America |
| Distribution | US |
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
Due to products being shipped/distributed to customers after the products expiration date had past.
Identifiers
| code_info | Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Nihon Kohden America recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0314-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.