Emano Flow Software Recall Due to Sampling Rate Issue
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Emano Metrics, Inc. recalls 685 units of Emano Flow v2.0.0 software after audio recordings were captured at the wrong sampling rate, producing biased urinary flow measurements.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
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. This mismatch produced systematically biased Qmax, Qmean, and voided-volume estimates that usually over-reported flow rate and volume.
Which Products Are Affected
Emano Flow with software version v2.0.0 (GS1 GTIN code: 199874903484). The product is a smartphone-based acoustic uroflowmetry system distributed digitally via mobile application. 685 units are affected under recall number Z-2777-2026. Distribution occurred nationwide in the states of AR, AZ, CA, CO, FL, IA, ID, NC, NJ, PA, TX and WI.
What You Should Do
Corrected results have been made available to care teams. Consumers should contact their care teams regarding any affected measurements.
Why This Matters
The recall involves a Class II medical device whose incorrect measurements could affect clinical assessments of urinary flow.
Source
FDA recall Z-2777-2026, Emano Metrics, Inc., Eugene, OR.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,059 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.