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

Recall Insight

This FDA Devices action (record #Z-1292-2022) was formally reported on July 6, 2022, with the manufacturer initiating the action on April 21, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Dain Technology, Inc. (Subsidiary of Soundable Health, Inc.) is listed as the recalling firm, operating out of Seoul. Federal records indicate 41 devices (out of 1,260 users) units are affected, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide. The software app is distributed via the Apple App Store.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.