Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic uroflo
Summary
The FDA issued a Class II for Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Fl by Emano Metrics, Inc.. 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.
Details
Source
Device Recall
External ID
Z-2777-2026
Action Date
2026-07-29
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
Quantity Affected: 685
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.
Distribution
U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-29
Company
Eugene, OR
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 154 device recalls issued in the same week, part of 373 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Emano Metrics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Emano Metrics, Inc. have FDA actions?
This is the only FDA action we have on record for Emano Metrics, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2777-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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