Reported Nov 6, 2024 · Ongoing
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,…
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?
- Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
- Lot codes and dates
- Model num.: 809030006
- UDI-DI06970758500173 All lot numbers
- Amount recalled
- 67
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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