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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Nihon Kohden Adult Cap-ONE Biteblocks Recalled for Shipping After Expiration

Agency Publication Date: November 6, 2024
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Summary

Nihon Kohden America Inc. is recalling 17 Adult Cap-ONE Biteblocks (model YG-227T) because they were distributed to customers after their expiration dates had passed. These single-use devices are used to sample carbon dioxide and provide supplemental oxygen to patients during endoscopy procedures. No injuries or incidents have been reported, but the company is taking action to retrieve the expired units.

Risk

Using a medical device beyond its expiration date may result in reduced monitoring accuracy or compromised product sterility, potentially leading to infections or improper patient care during medical procedures.

What You Should Do

  1. The recalled products are Adult Cap-ONE Biteblocks, model YG-227T (DI: 14931921904043), with lot numbers 706121CB, 706301CB, and 707211CB.
  2. Stop using the recalled device immediately.
  3. Contact Nihon Kohden America Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of the expired products.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Adult Cap-ONE Biteblock
Variants: Adult, 20mm bite block
Model / REF:
YG-227T
Lot Numbers:
706121CB
706301CB
707211CB
UDI:
14931921904043

Intended to sample CO2 and administer supplemental oxygen during endoscopy procedures; single patient use only.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95480
Status: Active
Manufacturer: Nihon Kohden America Inc
Sold By: Authorized medical distributors
Manufactured In: United States
Units Affected: 17 devices
Distributed To: California, Georgia, Idaho, Kentucky, Massachusetts, Missouri, North Carolina, Oregon, Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.