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MEDICAL DEVICE RECALLMODERATE

Emano Flow v2.0.0

Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.

What to do

Contact Emano Metrics to obtain corrected results for your care team.

Recalled
Listed
Updated
Recall No.
Z-2777-2026
Agency
FDA
Firm
Emano Metrics, Inc.
Recall ID
99241
Status
ONGOING

Why it was recalled

Emano Metrics is recalling Emano Flow software version v2.0.0 because urination audio was recorded at 48,000 Hz but processed against models trained on 44,100 Hz audio, producing systematically biased Qmax, Qmean, and voided-volume estimates. The problem usually over-reports flow rate and volume.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

Other Device Defect recalls

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Editorial summary by Recall Canary · summary updated 2026-07-23 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification