Class II — NOX MEDICAL
| Recalling firm | Nox Medical |
|---|---|
| Registered facility | NOX MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Error in the device firmware results in the inaccurate detection of device position. |
| Product | Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep. |
| Quantity | 128 units |
| Distribution | US Nationwide distribution in the states of OH, IL, GA, IA, CA, PA, NM, MI, SD. |
| Initiated | 2021-09-07 |
| Classified | 2021-10-05 |
| Terminated | 2023-05-01 |
| Recall number | Z-0031-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — NOX MEDICAL (Z-0031-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88673/
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