Adult Cap-ONE Biteblock devices recalled for expired product distribution
Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices shipped after expiration dates. The single-use devices are intended for sampling CO2 and administering oxygen during endoscopy procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is distribution of expired medical devices—a regulatory and quality compliance issue rather than an acute safety threat. The small quantity affected (17 devices) and absence of reported harm support a Moderate severity rating.
Plain-English summary
Nihon Kohden America Inc is recalling 17 Adult Cap-ONE Biteblock devices (Model YG-227T, Lot Numbers 706121CB, 706301CB, 707211CB) that were shipped and distributed to customers after the devices' expiration dates had passed. The Cap-ONE Biteblock is intended for sampling carbon dioxide and administering supplemental oxygen during endoscopy procedures for patients who can wear a 20mm bite block.
The affected devices were distributed to healthcare facilities in California, Georgia, Idaho, Kentucky, Massachusetts, Missouri, North Carolina, Oregon, and Utah. Devices that exceed their expiration date may not function as originally designed or tested.
The recalled product
- 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.
- Manufacturer
- Nihon Kohden America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model:YG-227T DI: 14931921904043 Lot Numbers: 706121CB
- 706301CB
- 707211CB
Distribution
Related recalls
Same manufacturer · Nihon Kohden America Inc
See all →- HighNihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
FDA (Devices) · 2024-11-06
- HighNihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
FDA (Devices) · 2024-11-06
- HighBedside Monitor Software Issue Causes False Oxygen Saturation Probe Failure Alarms
FDA (Devices) · 2024-06-12
- ModerateNihon Kohden Telemetry Recalled for Incorrect Date Stamp or No Data Transfer
FDA (Devices) · 2021-03-10
- ModerateNihon Kohden PSG-1100 Sleep Diagnostic System Recalled for Electrical Safety Non-Conformance
FDA (Devices) · 2021-02-03
Same hazard · expired product
See all →- ModerateExpressaire Disposable Tourniquet Cuff Recalled for Incorrect Expiration Date
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateFDA Recalls Expressaire Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- HighNihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance
FDA (Devices) · 2024-11-06
- HighNihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval
FDA (Devices) · 2024-11-06
- HighEZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures
FDA (Devices) · 2024-02-07
- ModerateSouthmedic Oxygen Masks Recalled Due to Potential CO2 Diffuser Issues
FDA (Devices) · 2018-04-11
- ModerateCook Drainage Catheter Recall: Incorrect Expiration Date Labels
FDA (Devices) · 2024-07-03
- HighWestmed Adult CO2/O2 Mask Recall Due to Loose Tube Fitment
FDA (Devices) · 2021-01-06