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Emano FlowRecalls & reported problems

Emano Metrics Inc. · Emano Flow is a prescription-use smartphone software application that analyzes audio recordings of urination to measure urinary flow rate and voided volume in male patients with lower urinary tract symptoms. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. May 29, 2026Open, Classified

    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.

    Z-2777-2026 · Root cause: Software Design Change · FDA record ↗

Other Uroflowmeter devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.