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

Recall Insight

This FDA Devices action (record #Z-0267-2025) was formally reported on November 6, 2024, with the manufacturer initiating the action on September 18, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Nihon Kohden America Inc is listed as the recalling firm, operating out of Irvine, CA. Federal records indicate 67 units are affected.

The documented reason for this recall is: Due to oximeters not having FDA market approval or clearance to distribute in the U.S. Distribution data in the federal record shows the product reached: 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. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.