Z-2777-2026Class II

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic...

Name: Z-2777-2026 Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic...
Creator: Emano Metrics, Inc.
Published: 2026-05-29
License: https://open.fda.gov/license/

Emano Metrics, Inc. / initiated 2026-05-29 / Open, Classified / root cause: software

FDA source

Emano Metrics, Inc. began a recall of 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... on 2026-05-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2777-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-29
Posted: 2026-07-22
Recalling firm: Emano Metrics, Inc.
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.
Product code: EXY Uroflowmeter
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.
Root cause tag: software
FDA root cause: Software Design Change
Action: On 06/10/2026, a "Medical Device Correction" Letter was emailed to customers informing them that it would found that Emano Flow software versions v2.2.0-v2.3.4 processed audio at a sample rate that did not match the sample rate expected by the flow prediction algorithms (model version v2.0.0), affecting results generated between 03/22/2026 to 05/29/2026. Customer were also informed that, the correction (updated software) was deployed on May 29, 2026. An updated customer notice was emailed on 06/23/2026. Instructions provided to Customer included: 1. Review the corrected results for patients with Emano Flow data from the affected period, prioritizing cases where the data informed a clinical decision. 2. If customers have previously downloaded patient reports generated between 03/22/2026 and 05/29/2026, replace them with the corrected versions available in the Emano Flow clinic portal. A spreadsheet with secure links to all corrected reports is attached. 3. Please reply to this email to confirm receipt of this notice.
Quantity in commerce: 685
Distribution: U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Product codes and lots: Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2777-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2777-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code EXY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)