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Nihon Kohden America Inc recalls Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult,
Recalled November 6, 2024 · FDA recall Z-0267-2025 · Nihon Kohden America
Hazard
Due to oximeters not having FDA market approval or clearance to distribute in the U.S. · FDA Class II
Units
67
Sold at
U.S.: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, KS, MA, MD, MI, MO, MT, NC, ND, NE, NH, OK, PA, SC, TX, VT, WA, and WI. O.U.S.: N/A
Description
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Manufacturer(s)
Nihon Kohden America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →