Nihon Kohden America Inc: Medical Device Recall in 2024 - (Recall #: Z-0314-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 29, 2022

Date Posted: November 13, 2024

Recall Number: Z-0314-2025

Event ID: 95480

Reason for Recall:

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

Status: Ongoing

Product Quantity: 17 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated