United StatesEmano Flow smartphone-based acoustic uroflowmetry system, software version v2.0.0 (GS1 GTIN 199874903484) distributed via mobile application is affected. Between March 22, 2026 and May 29, 2026 recorded urination audio was captured at 48,000 Hz while the model was trained on 44,100 Hz audio, producing systematically biased and usually over‑reported Qmax, Qmean, and voided-volume estimates. The firm has made corrected results available to care teams.
What's being recalled
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system. Software-only device that measures urinary flow rate and voided volume from the acoustic signal of urination. No physical components. Distributed digitally via mobile application.
Recalling firm: Emano Metrics, Inc., Eugene, OR, United States.
How to identify it
Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
The hazard
Problem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. The models depend on the sampling so every recording in the window was therefore processed against a time/frequency scale the models did not expect, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)