Reported Nov 13, 2024 · Ongoing

Adult Cap-ONE Biteblock REF YG-227T The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen,…

Nihon Kohden America Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Nihon Kohden America Inc · 15353 Barranca Pkwy · Irvine, CA · 92618-2216

Is this the product you have?

  • 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.
Lot codes and dates
  • ModelYG-227T
  • DI14931921904043
  • Lot Numbers
    • 706121CB
    • 706301CB
    • 707211CB
Amount recalled
17 devices

Where it was sold

Why it was recalled

Due to products being shipped/distributed to customers after the products expiration date had past.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:43 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.