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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90165

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 21, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.)

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1292-2022
Recall number
Z-1292-2022
Initiated
April 21, 2022
Classification
Class II
Status
Terminated
Quantity
41 devices (out of 1,260 users)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.