Nihon Kohden recalls adult ear clip SpO2 sensors without FDA approval for U.S. use. This device may not meet safety standards, but no specific action is required.
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Nihon Kohden is recalling adult ear clip SpO2 sensors that were sold without FDA approval in the U.S. This means the product may not meet safety standards, but no action is needed for consumers.
The device was sold without FDA approval in the U.S., meaning it may not meet safety standards. This could lead to potential health risks if used improperly, but the exact hazard is not specified.
People who own the recalled ear clip SpO2 sensors may be affected. Those using medical devices without proper regulatory approval are at risk.
Check for the model number 809030007 on the device. The product was sold with UDI-DI: 06970758500159 and all lot numbers.
Look for the model number 809030007 on the ear clip SpO2 sensor.
The device was sold without FDA approval in the U.S., meaning it may not meet safety standards.
No specific action is required as the recall does not include a remedy.
The model number 809030007 is affected, with UDI-DI: 06970758500159 and all lot numbers.
We’ve drafted a message you can send Nihon Kohden to request your refund or repair — edit it as you like.
Subject: Recall Z-0268-2025 — Nihon Kohden Nihon Kohden Hello, I own a Nihon Kohden that is covered by recall Z-0268-2025 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.
