Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.): Medical Device Recall in 2022 - (Recall #: Z-1292-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: April 21, 2022
Date Posted: July 6, 2022
Recall Number: Z-1292-2022
Event ID: 90165
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.

Status: Terminated
Product Quantity: 41 devices (out of 1,260 users)
Code Information:

prouP Version - 1.2.0 UDI Code: (01)00860006184902(10)v1.x.x

Distribution Pattern:

Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.

Voluntary or Mandated:

Voluntary: Firm initiated