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Recall Observatory FDA recall evidence

Device product

Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box

Z-0267-2025

September 18, 2024

Class II

Product summary

Firm
Nihon Kohden America Inc
Event
Event 95426
Status
Ongoing
Classification
Class II
Quantity
67
Official record key
device-enforcement:Z-0267-2025

Official wording

Reason: Due to oximeters not having FDA market approval or clearance to distribute in the U.S.

Code information: Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to oximeters not having FDA market approval or clearance to distribute in the U.S.