Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is... recall (Emano Metrics, Inc.)
Medical deviceClass IIOngoing
Summary: Emano Metrics, Inc. is recalling 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 mobil. 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.
What is being recalled
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.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI. (states named: Arkansas, Arizona, California, Colorado, Florida, Iowa, Idaho, North Carolina, New Jersey, Pennsylvania, Texas, Wisconsin)
How to tell if yours is affected
Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2777-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 29, 2026 |
| Reported | July 29, 2026 |
| Company | Emano Metrics, Inc. |
| Company location | Eugene, OR, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 685 |
More recalls from Emano Metrics, Inc. · all medical device recalls · recalls from May 2026