Lower risk Medical device recall · FDA · Published May 29, 2026

Emano Flow v2.0.0 Software Issue: Accurate Urine Flow Measurements

Emano Metrics recalls v2.0.0 software for Emano Flow devices due to inaccurate urine flow measurements. The software version may over-report flow rates and volumes, affecting medical assessments.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2777-2026Medical device Emano Metrics ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

Emano Metrics recalls Emano Flow devices with software version v2.0.0 because they inaccurately measure urine flow rates and volumes. This could lead to incorrect medical assessments if used for health monitoring. Read more at govinfonow.com/recall/127854-emano-flow-v2-0-0-software-issue-accurate-urine-flow.

Source Summary by GovInfoNow · govinfonow.com/recall/127854-emano-flow-v2-0-0-software-issue-accurate-urine-flow · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2777-2026

Cite this page

“Emano Flow v2.0.0 Software Issue: Accurate Urine Flow Measurements.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127854-emano-flow-v2-0-0-software-issue-accurate-urine-flow. Based on FDA recall #Z-2777-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2777-2026%22&limit=1).

Emano Metrics, Inc. recalled Emano Flow smartphone-based acoustic uroflowmetry system with software version v2.0.0 on May 29, 2026, according to the FDA. The device produces systematically biased flow rate and volume estimates due to a sampling frequency error. Owners should contact the firm for corrected results.

How to tell if you have it

Emano Flow, software version v2.0.0
GS1 GTIN code: 199874903484
UPC: 00199874903484

The hazard

Recorded urination audio was captured at 48,000 Hz while the model was trained and validated on 44,100 Hz audio. This mismatch produces systematically biased Qmax, Qmean, and voided-volume estimates that usually over-report flow rate and volume.

Context

GovInfoNow's records show other recent recalls of similar products include Philips EPIQ Elite Ultrasound System Recall (2026-08-07): Inaccurate Blood Flow Measurements.

How to tell if you have this one

Check if your Emano Flow device has software version v2.0.0. The product is identified by GS1 GTIN code 199874903484 and is distributed via mobile application.

Brand
Emano Metrics
Product
Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Update Software
Emano Metrics has provided corrected results for accurate measurements. Check for software updates through the mobile application.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 12 states.

FDA distribution: “U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Idaho, Iowa, New Jersey, North Carolina, Pennsylvania, Texas, Wisconsin.

Recall timeline

FDA published this recall 2 months after the firm started it.

May 29, 2026Firm started the recall
Jul 22, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Latest medical device recalls

Keep exploring

More Emano Metrics recalls

Link to this recall

<a href="https://govinfonow.com/recall/127854-emano-flow-v2-0-0-software-issue-accurate-urine-flow">Emano Flow v2.0.0 Software Issue: Accurate Urine Flow Measurements (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2777-2026 (May 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2777-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.