Nihon Kohden America Inc 2024-11-06 Health serious FDA
Health · FDA · Recall #FDA-Z-0268-2025
Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear… Recall
Issued November 6, 2024 · Nihon Kohden America Inc
In November 2024, Nihon Kohden America Inc recalled the Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
What you should do
- 1 Stop using Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Nihon Kohden America Inc to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Nihon Kohden America Inc
- Category
- Health
- Recall date
- November 6, 2024
- Units affected
- Not reported
- 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
- Recall number
- FDA-Z-0268-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Nihon Kohden America Inc has 2 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.