{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "221634", "product_res_number": "Z-2968-2026", "event_date_initiated": "2026-07-13", "event_date_posted": "2026-08-14", "recall_status": "Open, Classified", "res_event_number": "99478", "product_code": "DWJ", "k_numbers": [ "K110104" ], "product_description": "Blanketrol II Model 222S; Thermal regulating system.", "code_info": "UDI: 1061303186165 Serial Numbers:131-2-00580 through 262-3-20277", "firm_fei_number": "1516825", "recalling_firm": "Gentherm Medical, LLC", "address_1": "12011 Mosteller Rd Fl 3 12011 Mosteller Rd", "address_2": "Fl 3", "city": "Blue Ash", "state": "OH", "postal_code": "45241-1528", "reason_for_recall": "Overheating occurring on 115V CPU boards for the Blanketrol III Model 233, Innercool CoolBlue Model STx, and Blanketrol II Model 222S products may cause the device to shut down.", "root_cause_description": "Device Design", "action": "Genthem issued an URGENT Medical Device Notice to its consignees on 7/17/2026 via email. The notice explained the issue, potential risk, and request the following: \n\"Interim Recommendations:\n1. Based on the low probability of harm, and absence of reported harm, associated with this issue, users may continue to use the device. In an abundance of caution, it is recommended to have an alternative means of providing therapy available. \n2. Users should review and follow the device Instructions for Use; users should routinely verify the device s function and patient s condition during use. \n3. 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.\" \nFor questions or if you have experienced the described issue or a related adverse event, call Gentherm Medical Technical Support at 1-888-437-5608.", "product_quantity": "182 units", "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.", "openfda": { "k_number": [ "K232638", "K061513", "K132048", "K991684", "K071918", "K073712", "K200446", "K981093", "K950416", "K900186", "K071341", "K031728", "K913016", "K770839", "K960511", "K210605", "K251974", "K010338", "K772015", "K110104", "K101092", "K011907", "K231596", "K001546", "K243942", "K942881", "K003368", "K053645", "K963731", "K120849", "K902650", "K140635", "K190221", "K914382", "K051336", "K811743", "K141686", "K014210", "K910327", "K933764", "K930345", "K131361", "K142702", "K102856", "K260278", "K123946", "K221669", "K800812", "K200225", "K873745", "K180834", "K113705", "K162562", "K171149", "K964673", "K952864", "K820814", "K001149", "K943276", "K033021", "K024128", "K890575", "K132454", "K992386", "K921165", "K252861", "K181671", "K921920", "K230866", "K903360", "K021473", "K080763", "K060865", "K220941", "K946196", "K101148", "K912051", "K771537", "K101589", "K023934", "K920265", "K882442", "K964377", "K904690", "K882035", "K942790", "K161602", "K171234", "K881322", "K201779", "K761087", "K914805", "K260903", "K101705", "K210603", "K123083", "K020604", "K854856", "K181699", "K062794", "K120081", "K232508", "K812955", "K180375", "K920432", "K083336", "K152266", "K171373", "K940171", "K040632", "K083662", "K014121", "K061902", "K942599", "K231211", "K022903", "K051278", "K232844", "K093244", "K232502", "K970367", "K140078", "K232627", "K923104", "K002577", "K902756", "K052392", "K083135", "K973705", "K093694", "K914383", "K051097", "K041686", "K913734", "K040911", "K051419", "K801253", "K040440", "K873546", "K121720", "K202197", "K003349", "K952329", "K011859", "K952086", "K121669", "K262089", "K112488", "K894980", "K072513", "K203085", "K261437", "K094056", "K811742", "K092807", "K102112", "K070112", "K242964", "K162679", "K100585", "K960167" ], "registration_number": [ "3009093866", "3008879776", "1725056", "3013041594", "3041276890", "3005997949", "3013188547", "8022590", "1220351", "3014263632", "9616567", "3007309299", "2432320", "3010476117", "1836518", "3003857828", "1516825", "9616096", "3013557562", "3009746061", "3012315097", "3007616088", "3012421607", "9617473", "3036108847", "3010168054", "3012972101", "3013319212", "3014426939", "3032911850", "9610849", "2029015", "3012494290", "3043226252", "9611590", "1066427", "1043214", "1055236", "3005941719", "1000484830", "2936999", "3034393266", "3010317211", "3035108304", "3008352384", "3021073836", "2183744", "3031841433", "1722070", "1055823", "3013410562", "2530138", "9617604", "1043644", "3029871637", "1043572", "1000122786", "3008727520", "1417592", "3011059079", "3014421917", "2032112", "2183613", "1054241", "3016507522", "3003542872", "3005238200", "2320762", "2011171", "3004362278", "3016844398", "2133810", "3044156918", "1060680", "3012689738", "3005857264", "3042272797", "9680284", "9614306", "3006240053", "3010380518", "2133641", "3038241934", "3004491421", "3010617000", "1018233", "3009609358", "1219702", "2025816", "3018094310", "3030597679" ], "fei_number": [ "3009093866", "1000112968", "3008879776", "3013041594", "3041276890", "3005997949", "3013188547", "1220351", "3003040625", "3014263632", "3002807391", "3003807323", "3007309299", "3007513035", "3003793491", "3010476117", "3002963732", "3003076831", "1000208624", "3003857828", "1516825", "3013557562", "3002558692", "3009746061", "3001733054", "3495", "3012315097", "3007616088", "3012421607", "3036108847", "3010168054", "3012972101", "1000521377", "3013319212", "3014426939", "1000221205", "3032911850", "1000111140", "3002809016", "3012494290", "3043226252", "1043214", "1000484830", "2936999", "3034393266", "3010317211", "3035108304", "3008352384", "1000160458", "3021073836", "1000117260", "2183744", "3031841433", "3013410562", "3003261020", "1043644", "3003753496", "3029871637", "1043572", "1000122786", "3008727520", "3003329224", "1417592", "3011059079", "3014421917", "2183613", "3016507522", "3003542872", "3005238200", "3000203066", "2011171", "3004362278", "3016844398", "3044156918", "3002807111", "3012689738", "3005857264", "3042272797", "3006240053", "3010380518", "3038241934", "3004491421", "1000237915", "1018233", "3009609358", "1219702", "2025816", "1000112877", "3000203466", "3018094310", "3030597679" ], "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ] }