CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
Emano Flow recalled by Emano Metrics
Emano Metrics is recalling Emano Flow, distributed nationwide in the US. The recall was initiated on 29 May 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2777-2026
- FDA event ID
- 99241
- Recalling firm
- Emano Metrics, Eugene, OR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 May 2026
- FDA classified
- 22 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 29 May 2026 | Recall initiated by company | |
| 22 Jul 2026 | Classified by FDA | +54 days |
| 29 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Nationwide ArkansasArizonaCaliforniaColoradoFloridaIowaIdahoNorth CarolinaNew JerseyPennsylvaniaTexasWisconsin
Questions about this recall
Is Emano Flow recalled?
Yes. Emano Metrics recalled Emano Flow on 29 May 2026. The recall is Class II and its status is Ongoing. Recall number Z-2777-2026.
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.
Which lots are affected?
Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
Where was it sold?
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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