{"url_path":"/fda/device/recalls/Z-2968-2026","section_key":"summary","section_title":"DEVICE Recall: Gentherm Medical, LLC — Blanketrol II Model 222S; Thermal regulating system.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-13","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2968-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Gentherm Medical, LLC"},"word_count":97,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2968-2026\n\n**Recalling firm:** Gentherm Medical, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-13\n**Report date:** 2026-08-26\n\n## Product\nBlanketrol II Model 222S; Thermal regulating system.\n\n## Reason\nOverheating of the 115V CPU board may cause the device to shut down.\n\n## Affected lots\nUDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277\n\n## Distribution\nWorldwide - 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."}