Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 recall
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Why was Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 recalled?
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
- Product
- Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
- Recalling firm
- Nihon Kohden America Inc
- Quantity
- 67
- 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
- Recall date
- November 6, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)