FDA recall, , Moderate risk
Emano Flow
The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.
Summary by Recall Canary from the FDA notice
What happened
Emano Metrics, Inc., of Eugene, Oregon, recalled Emano Flow with software version v2.0.0, a smartphone-based acoustic uroflowmetry system that measures urinary flow rate and voided volume from the acoustic signal of urination.
The FDA noted that 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, so 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 company began the recall on May 29, 2026.
The product was distributed digitally via a mobile application nationwide in the states of AR, AZ, CA, CO, FL, IA, ID, NC, NJ, PA, TX and WI.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484
- UDI-DI
- 199874903484
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of Arkansas, Arizona, California, Colorado, Florida. Iowa, Idaho, North Carolina, New Jersey, Pennsylvania, Texas and Wisconsin.
- Company
- Emano Metrics, Inc.Eugene, Oregon
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99241
- Recall number
- Z-2777-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
