{"recall":{"id":"fda-device-99035","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Hamilton Medical AG recalls IntelliCuff","firm":"Hamilton Medical AG","date":"2026-05-22","reported":"2026-07-08","status":"Ongoing","classification":"Class II","products":[{"name":"IntelliCuff, Portable automatic cuff pressure controller REF: 951001","code":"GTIN: 07630002800839/ Lot # range: 00001 -19732","quantity":"962 units","number":"Z-2625-2026","classification":"Class II"}],"reason":"Due to reported complaints, the cuff device may alarm with a \"Cuff System Leakage\" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, \tND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.","nationwide":true,"states":[],"units":"962 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=99035","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"23f500c0cdfa8684","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=99035","record":[{"status":"Ongoing","city":"Domat/Ems","state":"N/A","country":"Switzerland","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99035","recalling_firm":"Hamilton Medical AG","address_1":"Parc Industrial Vial 10","address_2":"N/A","postal_code":"N/A","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IL, KY, MA, MI, \tND, NE, NE, NY, OH, PA, PR, SD, TX, VA, WA, WI, WV, WY and the country of Canada.","recall_number":"Z-2625-2026","product_description":"IntelliCuff, Portable automatic cuff pressure controller  REF: 951001","product_quantity":"962 units","reason_for_recall":"Due to reported complaints, the cuff device may alarm with a \"Cuff System Leakage\" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.","recall_initiation_date":"20260522","center_classification_date":"20260701","report_date":"20260708","code_info":"GTIN: 07630002800839/ Lot # range: 00001 -19732"}]}}