{"recall":{"id":"fda-device-99241","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Emano Metrics, Inc. recalls Emano Flow with software version v2","firm":"Emano Metrics, Inc.","date":"2026-05-29","reported":"2026-07-29","status":"Ongoing","classification":"Class II","products":[{"name":"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.","code":"Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress","quantity":"685","number":"Z-2777-2026","classification":"Class II"}],"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 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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.","nationwide":true,"states":[],"units":"685","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99241","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c45c8d423d898c16","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99241","record":[{"status":"Ongoing","city":"Eugene","state":"OR","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99241","recalling_firm":"Emano Metrics, Inc.","address_1":"132 E Broadway Ste 101","address_2":"N/A","postal_code":"97401-3150","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the states of AR, AZ, CA, CO, FL. IA, ID, NC, NJ, PA, TX and WI.","recall_number":"Z-2777-2026","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.","product_quantity":"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.","recall_initiation_date":"20260529","center_classification_date":"20260722","report_date":"20260729","code_info":"Software Version - 2.0.0 GS1 GTIN code: 199874903484 UDI code: GUDID registration is in progress"}]}}