Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

Recall Insight

This FDA Devices action (record #Z-0031-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on September 7, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. NOX MEDICAL is listed as the recalling firm, operating out of Reykjavik. Federal records indicate 128 units units are affected.

The documented reason for this recall is: Error in the device firmware results in the inaccurate detection of device position. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD.. 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 5 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.