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U.S. Department of Health and Human Services

Class 2 Device Recall Emano Flow

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 Class 2 Device Recall Emano Flowsee related information
Date Initiated by FirmMay 29, 2026
Date PostedJuly 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2777-2026
Recall Event ID 99241
Product Classification Uroflowmeter - Product Code EXY
ProductEmano 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.
Code Information Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
FEI Number 3021350028
Recalling Firm/
Manufacturer		 Emano Metrics, Inc.
132 E Broadway Ste 101
Eugene OR 97401-3150
For Additional Information ContactEdouard Hay
541-434-4414
Manufacturer 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.
FDA Determined
Cause 2		Software Design Change
ActionOn 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 Commerce685
DistributionU.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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