{"recall":{"id":"fda-device-99478","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Gentherm Medical, LLC recalls 3 products","firm":"Gentherm Medical, LLC","date":"2026-07-13","reported":"2026-08-26","status":"Ongoing","classification":"Class II","products":[{"name":"Blanketrol II Model 222S; Thermal regulating system.","code":"UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277","quantity":"182 units","number":"Z-2968-2026","classification":"Class II"},{"name":"Innercool Coolblue Console, Model STx; Thermal regulating system.","code":"UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277","quantity":"46 units","number":"Z-2969-2026","classification":"Class II"},{"name":"Blanketrol III, Model 233; Thermal regulating system.","code":"UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307, Serial Numbers:131-2-00580 through 262-3-20277","quantity":"9714 units","number":"Z-2970-2026","classification":"Class II"}],"reason":"Overheating of the 115V CPU board may cause the device to shut down.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.","nationwide":true,"states":[],"units":"182 units; 46 units; 9714 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=99478","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"8ab49ea45a1a043e","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=99478","record":[{"status":"Ongoing","city":"Blue Ash","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99478","recalling_firm":"Gentherm Medical, LLC","address_1":"12011 Mosteller Rd Fl 3","address_2":"","postal_code":"45241-1528","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.","recall_number":"Z-2968-2026","product_description":"Blanketrol II Model 222S; Thermal regulating system.","product_quantity":"182 units","reason_for_recall":"Overheating of the 115V CPU board may cause the device to shut down.","recall_initiation_date":"20260713","center_classification_date":"20260814","report_date":"20260826","code_info":"UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277","more_code_info":""},{"status":"Ongoing","city":"Blue Ash","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99478","recalling_firm":"Gentherm Medical, LLC","address_1":"12011 Mosteller Rd Fl 3","address_2":"","postal_code":"45241-1528","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.","recall_number":"Z-2969-2026","product_description":"Innercool Coolblue Console, Model STx; Thermal regulating system.","product_quantity":"46 units","reason_for_recall":"Overheating of the 115V CPU board may cause the device to shut down.","recall_initiation_date":"20260713","center_classification_date":"20260814","report_date":"20260826","code_info":"UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277","more_code_info":""},{"status":"Ongoing","city":"Blue Ash","state":"OH","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99478","recalling_firm":"Gentherm Medical, LLC","address_1":"12011 Mosteller Rd Fl 3","address_2":"","postal_code":"45241-1528","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"Worldwide - US Nationwide distribution including in the territories of Puerto Rico, and the countries of Brazil, Canada, Chile, Colombia, Costa Rica, El Salvador, Guatemala, Mexico, Republic of Panama, Saudi Arabia, Taiwan, Thailand, Bahamas, and Trinidad and Tobago.","recall_number":"Z-2970-2026","product_description":"Blanketrol III, Model 233; Thermal regulating system.","product_quantity":"9714 units","reason_for_recall":"Overheating of the 115V CPU board may cause the device to shut down.","recall_initiation_date":"20260713","center_classification_date":"20260814","report_date":"20260826","code_info":"UDI: 1061303186102, UDI: 1061303186107, UDI: 1061303186139, UDI: 1061303187107, UDI: 1061303187307,  Serial Numbers:131-2-00580 through 262-3-20277","more_code_info":""}]}}