Emano Metrics, Inc. recalls Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a sm

Recalling company

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 29, 2026

Reported

Jul 29, 2026

Distribution

U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.

Status

Ongoing

Quantity

685

Lot / codes

Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress

Company location

Eugene, OR

Recall type

Voluntary: Firm initiated

Recall number

Z-2777-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2777-2026 in the FDA Enforcement Report. Also see FDA recall press releases.