- Recalling firm
- Emano Metrics, Inc.
- 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.
- Affected products (lot / model / serial)
- Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress
- Units affected
- 685
- Distribution pattern
- U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.
- Firm location
- Eugene, OR, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2777-2026
- Recall initiated
- May 29, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99241
- Last updated on HTM Vibe
- August 4, 2026