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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.…
- Manufacturer
- Emano Metrics, Inc.
- Affected units
- 685
Distribution
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