CLASS II ONGOING Device recall · Reported 13 Nov 2024 · FDA Enforcement Report
Adult Cap-ONE Biteblock recalled by Nihon Kohden America
Nihon Kohden America is recalling Adult Cap-ONE Biteblock, distributed nationwide in the US. The recall was initiated on 29 Apr 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0314-2025
- FDA event ID
- 95480
- Recalling firm
- Nihon Kohden America, Irvine, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Apr 2022
- FDA classified
- 6 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 29 Apr 2022 | Recall initiated by company | |
| 6 Nov 2024 | Classified by FDA | +922 days |
| 13 Nov 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to products being shipped/distributed to customers after the products expiration date had past.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Nationwide CaliforniaGeorgiaIdahoKentuckyMassachusettsMissouriNorth CarolinaOregonUtah
Questions about this recall
Why was it recalled?
Due to products being shipped/distributed to customers after the products expiration date had past.
Which lots are affected?
Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Where was it sold?
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Nihon Kohden America
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|---|---|---|---|---|---|
| Device | CLASS II | Nihon Kohden CNS-6200 Series Central Nurse Station recalled | Nihon Kohden America | Device Malfunction | Nationwide |
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| Device | CLASS II | BSM-3000 Series Bedside Monitor recalled by Nihon Kohden America | Nihon Kohden America | Device Malfunction | Nationwide |
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