Emano Flow v2.0.0 smartphone uroflowmetry app recalled for inaccurate measurements
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 685
- Illnesses reported
- None reported
- Manufactured in
- 132 E Broadway Ste 101, N/A, Eugene, OR, United States
- Classification
- Class II
- Recall number
- Z-2777-2026
In the FDA's words
- Description
- 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. 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. Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress Distribution: U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI. Affected quantity: 685
- 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.