{"recall":{"id":"fda-device-99811","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Limitless Cryo Spa LLC recalls Glypto Device","firm":"Limitless Cryo Spa LLC","date":"2026-08-24","reported":"2026-10-14","status":"Ongoing","classification":"Class II","products":[{"name":"Glypto Device, Glypto Cryo Machine;","code":"All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented.","quantity":"219","number":"Z-0080-2027","classification":"Class II"}],"reason":"Lack of 510(k) clearance.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"US Nationwide distribution.","nationwide":true,"states":[],"units":"219","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=99811","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"426c04acf0a5644b","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=99811","record":[{"status":"Ongoing","city":"Ocean","state":"NJ","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99811","recalling_firm":"Limitless Cryo Spa LLC","address_1":"21 High Ridge Rd","address_2":"N/A","postal_code":"07712-3460","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"US Nationwide distribution.","recall_number":"Z-0080-2027","product_description":"Glypto Device, Glypto Cryo Machine;","product_quantity":"219","reason_for_recall":"Lack of 510(k) clearance.","recall_initiation_date":"20260824","center_classification_date":"20261002","report_date":"20261014","code_info":"All Glypto units distributed, placed, held, loaned, inventoried, or otherwise supplied by/through Limitless through the 08/11/2026 operational hold; 08/20/2026 preliminary field notice. Serial/account-specific consignee list attached or to be supplemented."}]}}