FDA Device recall Z-2777-2026
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system
- FDA Device
- Class II
- ongoing
- Published 2026-07-29
On 2026-07-29 the FDA classified a Class II recall of Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflowmetry system by Emano Metrics, citing 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 valida….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2777-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-29 |
| Published | 2026-07-29 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Emano Metrics |
| Distribution | US |
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.
Identifiers
| code_info | Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2777-2026%22
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