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Nihon Kohden America Inc recalls Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Recalled November 6, 2024 · FDA recall Z-0268-2025 · Nihon Kohden America
Hazard
Due to oximeters not having FDA market approval or clearance to distribute in the U.S. · FDA Class II
Units
64
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 Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
Manufacturer(s)
Nihon Kohden America Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →