Class II
Medical Device Recall: Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Nihon Kohden America Inc · September 18, 2024
Reason for Recall
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Distribution
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
States Affected
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, WI
Quantity Affected
67
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0267-2025
Status: ongoing
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