{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "175308", "product_res_number": "Z-0418-2020", "event_date_initiated": "2019-07-02", "event_date_created": "2019-11-18", "recall_status": "Terminated", "event_date_terminated": "2020-06-22", "res_event_number": "83464", "product_code": "DWJ", "k_numbers": [ "K110104" ], "product_description": "Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage: The system is composed of a heater, a compressor, a circulating pump and blankets/pads.", "code_info": "Model 222R (071-18490 through 123-20534) Model 222S (104-2-00001 through 161-2-01848)", "firm_fei_number": "1516825", "recalling_firm": "Cincinnati Sub-Zero Products LLC, a Gentherm Company", "address_1": "12011 Mosteller Rd", "city": "Cincinnati", "state": "OH", "postal_code": "45241-1528", "additional_info_contact": "SAME\n513-772-8810", "reason_for_recall": "Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue damage. Additionally, a caution was added and clarifications were made regarding the use of the Automatic modes", "root_cause_description": "Labeling False and Misleading", "action": "Gentherm issued URGENT Medical Device Correction, Blanketrol II letters were mailed by USPS starting July 25th and Blanketrol III letters were mailed by USPS starting July 30th. Letters stated problem, health risk and action to take: INSTRUCTIONS TO CUSTOMERS:\n1) Access updated manuals and ensure that obsolete manuals are removed from service. Updated manuals may be accessed via www.gentherm.com or physical copies may be requested from Gentherm Medical, LLC at (513)326-5320.\n2) Ensure that all users are informed of the contents of this letter. If you have further distributed this product, please provide those accounts with a copy of this notice.\n3) Please complete and return the enclosed response form as soon as possible to acknowledge receipt of this notification and to inform Gentherm Medical, LLC that you have performed and completed the requested actions. Return the form by e-mail to FA2019-004/010@gentherm.com, or mail to: Gentherm Medical, LLC, 12011 Mosteller Road, Cincinnati, OH 45241.\nQuestions, call Gentherm Medical Technical Support at 1-888-437-5608 or Stephanie Vocke @ (513)719-3262", "product_quantity": "3726", "distribution_pattern": "Worldwide distribution - US Nationwide and countries of \nAfghanistan, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bhutan, Brazil, Brunei, Canada\nChile, China, Colombia, Costa Rica, Ecuador, Egypt, El Salvador, France, Germany, Guatemala, Hong Kong, India, Indonesia, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, \nLebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, \nNew Zealand, Oman, Pakistan, Palestine, Panama, \nPhilippines, Qatar, Saudi Arabia, Singapore, South Africa, \nSouth Korea, Spain, Taiwan, Thailand, Trinidad and Tobago,\nTurkey, United Arab Emirates, Venezuela, Vietnam.", "openfda": { "k_number": [ "K072513", "K231211", "K920432", "K040911", 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