Data Foundry

Medical device recalls 2022

ProudP Everyday Uroflow Tracker Software Version 1 — Class II medical device recall Z-1292-2022

Terminated recall by Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.), reported 2022-07-06, distributed nationwide. Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform auto

Recall numberZ-1292-2022
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmDain Technology, Inc. (Subsidiary of Soundable Health, Inc.), Seoul, Korea (the Republic of)
Recall initiated2022-04-21
Classified2022-06-27
Reported by FDA2022-07-06
Terminated2023-09-29
DistributedNationwide (US)
UPC / GTIN / UDI-DI00860006184902

Product

ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

Reason for recall

Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination volume and velocity values than expected.

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-1292-2022. 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.