{"recall":{"id":"fda-device-99277","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Klowen Braces recalls KL Owen Custom Orthodontic Solution","firm":"Klowen Braces","date":"2026-06-08","reported":"2026-07-15","status":"Ongoing","classification":"Class II","products":[{"name":"KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,","code":"UDI/DI 10850061082029, Lot Numbers: 1779407586392-0, 1779138889952-0, 1778173992342-0","quantity":"3 units","number":"Z-2699-2026","classification":"Class II"}],"reason":"A product error defect may cause incorrect bracket placement.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution in the states of OH, TX, SC VA.","nationwide":true,"states":[],"units":"3 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=99277","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"37f3fa2120eccf25","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=99277","record":[{"status":"Ongoing","city":"Richardson","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99277","recalling_firm":"Klowen Braces","address_1":"1900 Firman Dr Ste 800","address_2":"N/A","postal_code":"75081-6769","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Telephone","distribution_pattern":"US Nationwide distribution in the states of OH, TX, SC VA.","recall_number":"Z-2699-2026","product_description":"KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,","product_quantity":"3 units","reason_for_recall":"A product error defect may cause incorrect bracket placement.","recall_initiation_date":"20260608","center_classification_date":"20260708","report_date":"20260715","code_info":"UDI/DI 10850061082029, Lot Numbers:  1779407586392-0, 1779138889952-0, 1778173992342-0"}]}}