Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-0314-2025

April 29, 2022

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 95480
Status
Ongoing
Classification
Class II
Quantity
17 devices
Official record key
device-enforcement:Z-0314-2025

Official wording

Reason: Due to products being shipped/distributed to customers after the products expiration date had past.

Code information: Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB

Distribution pattern: U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to products being shipped/distributed to customers after the products expiration date had past.

Field note

Send feedback

We'll only use this to respond to your feedback.