Reported Jul 29, 2026 · Ongoing
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic…
Emano Metrics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Emano Metrics, Inc. · 132 E Broadway Ste 101 · Eugene, OR · 97401-3150
Is this the product you have?
- Emano Flow with software version v2.0.0
- GS1 GTIN code199874903484 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
- Lot codes and dates
- Software Version - 2.0.0
- GS1 GTIN code199874903484
- UDI codeGUDID registration is in progress
- Amount recalled
- 685
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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