cap-ONE recallZ-0314-2025 · Nihon Kohden America Inc · initiated Apr 29, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nihon Kohden America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to products being shipped/distributed to customers after the products expiration date had past.
FDA root cause category: Process control
What the company is doing
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].
Recall details
- Recall number
- Z-0314-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 29, 2022
- Posted by the FDA
- Nov 6, 2024
- Recalling firm
- Nihon Kohden America Inc
- Quantity
- 17 devices
- Product code
- CCK
- FDA submissions
- K171765
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
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.
Code information (models, lots, serial numbers)
Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- cap-ONE YG-227TNihon Kohden Corporation · Endoscopic bite block1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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