{"recall":{"id":"fda-device-99307","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"THERANICA BIOELECTRONICS LTD recalls Nerivio Infinity","firm":"THERANICA BIOELECTRONICS LTD","date":"2026-03-23","reported":"2026-08-12","status":"Ongoing","classification":"Class II","products":[{"name":"Nerivio Infinity. Model/Catalog Number: FGD000100. Software Version: FW Version 4.1.2.0, App version 7.28.0.11","code":"Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11 GTIN: 7290017578118. Serial Number: NI2544-0300673.","quantity":"11,886 units","number":"Z-2855-2026","classification":"Class II"}],"reason":"Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user","nationwide":false,"states":[],"units":"11,886 units","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=99307","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"3030f1f6816b8ee3","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=99307","record":[{"status":"Ongoing","city":"Netanya","state":"","country":"Israel","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99307","recalling_firm":"THERANICA BIOELECTRONICS LTD","address_1":"Poleg Industrial Park","address_2":"45, Ha-Melakha","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit","distribution_pattern":"The product's entry point to the US is a 3PL warehouse from which it is being shipped to DME distributors or specialty pharmacy who perform the shipment to the end-user","recall_number":"Z-2855-2026","product_description":"Nerivio Infinity. Model/Catalog Number: FGD000100.   Software Version: FW Version 4.1.2.0, App version 7.28.0.11","product_quantity":"11,886 units","reason_for_recall":"Potential for the batter to have a thermal-runway event during charging, resulting in smoke and odor.","recall_initiation_date":"20260323","center_classification_date":"20260731","report_date":"20260812","code_info":"Model/Catalog Number: FGD000100. UDI: 01072900175781181125120221NI2544-0300673 Software Version: FW Version 4.1.2.0, App version 7.28.0.11  GTIN: 7290017578118.  Serial Number: NI2544-0300673.","more_code_info":""}]}}