The Recall Desk
HighFDA (Devices)·Z-2777-2026·Announced 2026-07-29

Emano Flow Uroflowmetry App Recalled Over Biased Flow Estimates

Emano Metrics is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry app (v2.0.0) because recordings captured at 48,000 Hz were processed by models trained on 44,100 Hz audio, producing systematically biased urinary flow rate and voided volume estimates.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with no reported illness or injury; the hazard is a risk-of-harm product (biased medical measurements) where injury has not yet been reported, which falls under the High severity criterion.

Plain-English summary

Emano Metrics, Inc. is recalling 685 units of the Emano Flow smartphone-based acoustic uroflowmetry system, software version 2.0.0 (GS1 GTIN code 199874903484). The device is a software-only mobile application that measures urinary flow rate and voided volume from the acoustic signal of urination, with no physical components.

The recall is due to a software model mismatch. During 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. Because the models depend on the sampling rate, every recording in that window was 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 recall affects U.S. nationwide distribution in the states of AR, AZ, CA, CO, FL, IA, ID, NC, NJ, PA, TX, and WI. Care teams have been provided with corrected results.

Consumers and care teams should contact Emano Metrics, Inc. for information about the corrected software version and updated results.

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
Manufacturer
Emano Metrics, Inc.
Category
Medical Device — Urology / Diagnostic Software
Hazard
  • software-error
  • measurement-bias
  • diagnostic-accuracy

Distribution

Distributed nationwide across the United States.

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