Uroflowmetry App Recall: Emano Flow
Announced 2026-07-29 · FDA
685 units of Emano Flow software version v2.0.0 were distributed nationwide in AR, AZ, CA, CO, FL, IA, ID, NC, NJ, PA, TX and WI. The recordings were captured at 48,000 Hz but the model was trained/validated on 44,100 Hz, producing biased Qmax, Qmean, and voided-volume estimates, typically over-reporting flow and volume. Corrected results have been made available to care teams.
| Brand | Emano Metrics, Inc. |
|---|---|
| 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. |
| Reason | 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. |
| Severity | moderate |
| Units affected | 685 |
| Distribution | U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI. |
| Agency | FDA |
| Recall / campaign no. | Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress |
WHAT YOU SHOULD DO
- Update the Emano Flow app to the latest version when available.
- If you used the app for clinical decisions during the recall period, review measurements with your clinician using the corrected results.
- Contact Emano Metrics support or your healthcare provider with questions or for verification of your device version.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.