Z-0314-2025Class II

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer...

Name: Z-0314-2025 Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer...
Creator: Nihon Kohden America Inc
Published: 2022-04-29
License: https://open.fda.gov/license/

Nihon Kohden America Inc / initiated 2022-04-29 / Open, Classified / root cause: manufacturing process

FDA source

Nihon Kohden America Inc began a 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 can wear a 20mm bite... on 2022-04-29. FDA classified it as Class II and gives the reason as "Due to products being shipped/distributed to customers after the products expiration date had past". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0314-2025
Classification: Class II
Status: Open, Classified
Initiated: 2022-04-29
Posted: 2024-11-06
Recalling firm: Nihon Kohden America Inc
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 Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Due to products being shipped/distributed to customers after the products expiration date had past.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 05/02/2022, the firm emailed an "URGENT NOTIFICATION" to customers informing them that the YG-227T adult cap-ONE Biteblock were shipped/distributed past their labeled expiration date. Customers were instructed to: 01.Identify any YG-227T packages you have in inventory 02.Complete the attached Medical Device Notification Return Response Form 03.Email the completed Medical Device Notification Return Response Form back to NKA Technical Servicesat [email protected]. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and will either be exchanged for new YG-227T or a full refund will be issued for unused product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email [email protected].
Quantity in commerce: 17 devices
Distribution: U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
Product codes and lots: Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0314-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0314-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-06

Product code CCK

K171765Class IINihon Kohden CO2 MonitorNihon Kohden Corporation / cleared 2017-10-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)