FDA Medical devices recall ·
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano… recall
- Recall number
- Z-2777-2026
- Date
- (initiated May 29, 2026)
- Company / brand
- Emano Metrics, Inc.
132 E Broadway Ste 101, Eugene, OR, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 685
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
Distribution
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
States: Arkansas Arizona California Colorado Florida Iowa Idaho North Carolina New Jersey Pennsylvania Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2777-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.