Z-2777-2026 Class II Ongoing
FDA device recall Z-2777-2026 was initiated by Emano Metrics, Inc. on May 29, 2026 and is designated Class II. Reason for recall: 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 audi… The recall status is ongoing. Affected quantity: 685.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- May 29, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 685
Product Description
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 for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Code Information
Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress