FDA-Device2026-07-29Class IIPROCESSING DEFECT

Emano Flow v2.0.0 smartphone uroflowmetry app recalled for inaccurate measurements

OTHERNationwide distributionMedical devices

What this means

Emano Flow, a smartphone app that measures urinary flow rate and volume, produced inaccurate results during a two-month period (March 22–May 29, 2026). The app recorded audio at an incorrect frequency setting, causing measurements to be systematically over-reported. The company has provided corrected results to healthcare teams.

If you use Emano Flow and received measurements during March 22–May 29, 2026, contact your healthcare provider to review corrected results.
Update to the latest version of the app when available.
Contact Emano Metrics, Inc. with questions about your affected recordings.

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.

Affected count

685

Manufactured in

132 E Broadway Ste 101, N/A, Eugene, OR, United States

Products

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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2777-2026

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