Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1292-2022 — ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version 1.2.0 or earlier

U.S. FDA — Device Enforcement · Korea (the Republic of) · 2022-04-21 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1292-2022
Date of alert
2022-04-21
Country / jurisdiction
Korea (the Republic of)
Risk level
Class II
Risk type
recall
Brand
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860006184902
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.