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MEDICAL DEVICE RECALLMODERATE

Emano Flow v2.0.0

Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.

What to do

Contact Emano Metrics to obtain corrected results for your care team.

Posted
Updated
Agency
Firm
Emano Metrics, Inc.
Recall ID
99241
Status
ONGOING

Why it was recalled

Emano Metrics is recalling Emano Flow software version v2.0.0 because urination audio was recorded at 48,000 Hz but processed against models trained on 44,100 Hz audio, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume.

Is mine affected?

This recall covers the product below. If you have it, yours is affected.

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.

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Editorial summary by Recall Canary · last updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification