Nihon Kohden recalls adult forehead SpO2 sensors due to lack of FDA approval for U.S. distribution. Affected models include 809030006 with specific lot numbers. Consumers should check their product details.
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Nihon Kohden is recalling adult forehead SpO2 sensors that were sold without FDA approval for U.S. use. This means the devices may not be safe for medical use in the United States.
The sensors were distributed without FDA approval, which means they may not meet U.S. safety standards. This could lead to inaccurate readings or potential health risks during medical monitoring.
Adult patients using the recalled forehead SpO2 sensors for medical monitoring in the U.S. are at risk due to the lack of FDA approval.
Check for the model number 809030006 on the device. The product was sold in boxes of 10 with specific lot numbers including 06970758500173.
Look for the model number 809030006 and lot numbers starting with 06970758500173 on the device packaging.
The product was distributed without FDA approval for U.S. medical use, which may not meet safety standards.
Check for the model number 809030006 and lot numbers starting with 06970758500173 on the device packaging.
The recall does not specify a remedy, so contact Nihon Kohden America Inc for further instructions.
We’ve drafted a message you can send Nihon Kohden to request your refund or repair — edit it as you like.
Subject: Recall Z-0267-2025 — Nihon Kohden Nihon Kohden Hello, I own a Nihon Kohden that is covered by recall Z-0267-2025 from Nihon Kohden. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
