{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "211525", "product_res_number": "Z-0841-2025", "event_date_initiated": "2022-03-14", "event_date_posted": "2025-01-10", "recall_status": "Completed", "res_event_number": "95913", "product_code": "DWJ", "product_description": "Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.", "code_info": "UDI-DI 00850011479582, Serial Numbers: 23010166, 23010167, 23010168, 23010169, 23010170, 23010171, 23010172, 23010173, 23010174, 23010175, 23010176, 23010177, 23010178, 23010179, 23010180, 23010181, 23010182, 23010183, 23010184, 23010185, 24020001, 24020002, 24020003, 24020004, 24020005, 24020006, 24030001, 24030002, 24030003, 24030004, 24030005, 24030021, 24030022, 24030023, 24030024, 24030025, 24030026, 24030027, 24030028, 24030029, 24030030, 24030016, 24030017, 24030018, 24030019, 24030020, 22120033, 24030011, 24030012, 24030013, 24030014, 24030015, 24030006, 24030007, 24030008, 24030009, 24030010, 24060001, 24060002, 24060003, 24060004, 24060005, 24060006, 24060007, 24060008, 24060009, 24060010, 24060024, 24060025, 24060026, 24060027, 24060028, 24060011, 24060012, 24060013, 24060014, 24060015.", "firm_fei_number": "3005857264", "recalling_firm": "Augustine Temperature Management, LLC", "address_1": "15305 Minnetonka Blvd", "city": "Minnetonka", "state": "MN", "postal_code": "55345-1512", "additional_info_contact": "Nic Raph\n952-465-3526", "reason_for_recall": "HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code \"EA POST\".", "root_cause_description": "Device Design", "action": "Augustine Temperature Management, LLC began correcting (installing ferrites and software updates) the affected devices February, 2022 and completed the actions in August 2023. The firm did not perform any notification to its consignees that corrections would be implemented.", "product_quantity": "77 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K912051", "K873745", "K942881", "K041686", "K946196", "K910327", "K251974", "K923104", "K180834", "K940171", "K921165", "K991684", "K970367", "K252861", "K022903", "K964377", "K220941", "K881322", "K210605", "K112488", "K132454", "K102112", "K992386", "K181699", "K040911", "K811743", "K071918", "K020604", "K121669", "K101589", "K120849", "K232502", "K083135", "K232638", "K800812", "K232627", "K914382", "K051097", "K002577", "K882442", "K950416", "K093694", "K060865", "K801253", "K771537", "K920265", "K051336", "K952864", "K014210", "K854856", "K080763", "K201779", "K210603", "K921920", "K132048", "K031728", "K001149", "K903360", "K920432", "K261437", "K040440", "K202197", "K242964", "K101705", "K772015", "K113705", "K181671", "K011859", "K083662", "K180375", "K014121", "K960511", "K141686", "K070112", "K820814", "K770839", "K110104", "K123083", "K131361", "K203085", "K914383", "K083336", "K890575", "K062794", "K061513", "K943276", "K101148", "K811742", "K882035", "K021473", "K902650", "K952086", "K930345", "K024128", "K003368", "K162679", "K981093", "K963731", "K960167", "K120081", "K071341", "K230866", "K162562", "K190221", "K171149", "K952329", "K894980", "K913016", "K221669", "K140635", "K121720", "K231596", "K001546", "K094056", "K051278", "K011907", "K973705", "K142702", "K072513", "K913734", "K942790", "K093244", "K061902", "K900186", "K140078", "K053645", "K003349", "K101092", "K873546", "K100585", "K033021", "K964673", "K260903", "K051419", "K904690", "K232844", "K023934", "K052392", "K914805", "K102856", "K232508", "K200446", "K010338", "K942599", "K152266", "K231211", "K092807", "K933764", "K161602", "K243942", "K171234", "K200225", "K073712", "K123946", "K260278", "K761087", "K171373", "K040632", "K812955", "K902756" ], "registration_number": [ "3042272797", "2029015", "3030597679", "1060680", "3010617000", "3004491421", "3009093866", "3008352384", "3007309299", "3011059079", "1417592", "3021073836", "2025816", "3008727520", "1219702", "9610849", "9617604", "3014421917", "3035108304", "3041276890", "3012972101", "9616096", "1055823", "2011171", "3009746061", "3018094310", "3008879776", "2032112", "3043226252", "2936999", "3010168054", "3006240053", "1043572", "3010476117", "2432320", "3007616088", "3009609358", "1725056", "3013319212", "9680284", "1220351", "3031841433", "3013410562", "3005941719", "3012494290", "1000484830", "3012421607", "1000122786", "3012315097", "3010380518", "1043214", "3005857264", "3013041594", "1722070", "3012689738", "1066427", "3014426939", "1043644", "3029871637", "2133810", "3010317211", "2133641", "9614306", "9611590", "3013557562", "3016844398", "3044156918", "3034393266", "8022590", "2183613", "3013188547", "1018233", "1055236", "3003857828", "3038241934", "3005997949", "9616567", "3003542872", "1516825", "2183744", "3004362278", "1836518", "3016507522", "2530138", "9617473", "1054241", "3032911850", "3036108847", "2320762", "3014263632", "3005238200" ], "fei_number": [ "3042272797", "3007513035", "3030597679", "3004491421", "3009093866", "3008352384", "3007309299", "1000208624", "3011059079", "1417592", "3003040625", "3021073836", "2025816", "3008727520", "3002807391", "3001733054", "1219702", "3014421917", "3035108304", "3041276890", "3012972101", "3002807111", "2011171", "3003076831", "3009746061", "3018094310", "3008879776", "3003807323", "3043226252", "2936999", "3010168054", "3006240053", "3000203466", "1043572", "3010476117", "3003261020", "3007616088", "3009609358", "3013319212", "1220351", "3031841433", "3013410562", "1000160458", "3495", "3012494290", "1000484830", "3012421607", "1000521377", "1000122786", "1000117260", "3012315097", "3010380518", "1043214", "3005857264", "3013041594", "1000112968", "3002963732", "3012689738", "3014426939", "1043644", "3029871637", "1000111140", "3010317211", "3003753496", "3003793491", "3013557562", "3016844398", "1000237915", "3044156918", "3034393266", "1000221205", "2183613", "3013188547", "3000203066", "1018233", "1000112877", "3003857828", "3002558692", "3038241934", "3005997949", "3003329224", "3003542872", "1516825", "2183744", "3004362278", "3016507522", "3032911850", "3036108847", "3002809016", "3014263632", "3005238200" ], "device_name": "System, Thermal Regulating", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5900", "device_class": "2" } } ] }