FDA Medical Device Recalls (openFDA)
Nihon Kohden America Inc: 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.
- Recall number
- Z-0314-2025
- 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.
- Status
- Open, Classified
- Initiated
- 2022-04-29
- Posted
- 2024-11-06
- Terminated
- not on file
- Reason
- Due to products being shipped/distributed to customers after the products expiration date had past.
- 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 VitalSignsTechSupport@nihonkohden.com. 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 VitalSignsTechSupport@nihonkohden.com.
- Quantity
- 17 devices
- Distribution
- U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.
- Lot, serial or model codes
- Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB, 706301CB, 707211CB
- 510(k) numbers
- ["K171765"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 2080783
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28