Emano Metrics, Inc.: Uroflowmeter
Emano Flow Uroflowmeter Recall Summary Emano Metrics is recalling Emano Flow software version v2.0.0, a smartphone app that measures urinary flow rate and volume, because recordings made between March 22 and May 29, 2026 were captured at the wrong audio frequency, causing the app to systematically overestimate flow rates and volume. The affected software was distributed nationwide. The company has provided corrected results to healthcare providers for patients who used the device during this period.
- Recalling firm
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-29
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e5c9058e-6127-45c8-88fd-bed89e810894