FDAFDA · Food and drugs·Recall number Z-0267-2025
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Published November 6, 2024 · Recall initiated: September 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nihon Kohden America Inc
- Distributor
- 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
- Lot
- Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.