Nihon Kohden SpO2 Forehead Sensor (Nihon Kohden) – FDA Approval Issue (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
Brand
Nihon Kohden America Inc
Lot Codes / Batch Numbers
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
Products Sold
Model num.: 809030006 UDI-DI: 06970758500173 All lot numbers
Nihon Kohden America Inc is recalling Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Foreh due to Due to oximeters not having FDA market approval or clearance to distribute in the U.S.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to oximeters not having FDA market approval or clearance to distribute in the U.S.
Recommended Action
Per FDA guidance
On 10/07/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" via certified mail or FedEx informing customers that the Sp02 sensor's intended use was not reviewed/evaluated by the FDA and does not have market approval or clearance for distribution in the U.S. Customers are instructed to: 1. Identify any Caremed SpO2 sensor packages you have in inventory and cease use of the affected product. 2. Complete the attached Medical Device Notification Return Response Form 3. Email the completed Medical Device Notification Return Response Form back to NKA Technical Services at vitalsignsTS@nihonkohden.com. Nihon Kohden is requesting all unused stock be returned to Nihon Kohden and a full refund will be issued for unused product. Please contact Nihon Kohden Technical Support to coordinate the return of the affected product. If you have questions about this notification or the form below, please call Nihon Kohden America at 1-800-325-0283, Option 2 (M-F, 8am-5pm PDT) or email vitalsignsTS@nihonkohden.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IA, KS, MD, MA, MI, MO, MT, NE, NH, NC, ND, OK, PA, SC, TX, VT, WA, WI
Page updated: Jan 10, 2026