FDA Medical devices recall ·
Adult Cap-ONE Biteblock recall
- Recall number
- Z-0314-2025
- Date
- (initiated April 29, 2022)
- Company / brand
- Nihon Kohden America Inc
15353 Barranca Pkwy, Irvine, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 17 devices
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Due to products being shipped/distributed to customers after the products expiration date had past.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Distribution
U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
States: California Georgia Idaho Kentucky Massachusetts Missouri North Carolina Oregon Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0314-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.