Nox T3s Recorder — Class II medical device recall Z-0031-2022
Terminated recall by NOX MEDICAL, reported 2021-10-13, distributed nationwide. Error in the device firmware results in the inaccurate detection of device position.
| Recall number | Z-0031-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | NOX MEDICAL, Reykjavik, Iceland |
| Recall initiated | 2021-09-07 |
| Classified | 2021-10-05 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 128 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 15694311111443 |
| Serial numbers | 300106385, 300106396, 300106397, 300106398, 300106399, 300106400, 300106407, 300106413, 300106414, 300106415, 300106416, 300106419, 300106420, 300106421, 300106422, 300106423, 300106424, 300106425, 300106426, 300106427, 300106469, 300106470, 300106475, 300106476, 300106477 and 103 more |
| Model numbers | 561111 |
Product
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Reason for recall
Error in the device firmware results in the inaccurate detection of device position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0031-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.