{ "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": "211523", "product_res_number": "Z-0840-2025", "event_date_initiated": "2022-03-14", "event_date_posted": "2025-01-10", "recall_status": "Completed", "res_event_number": "95913", "product_code": "DWJ", "product_description": "Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: \n1) Model # WC77, \n2) Model # WC77D (Demo), \n3) Model # WC77R (Refurbished); used in conjunction with Warming Blankets and Mattresses.", "code_info": "1) UDI-DI 00850011479025, Serial Numbers: 23070025, 23070046, 23110068, 23110069, 23110070, 23060075, 23110107, 23120116, 20100003, 24040009, 24040010, 24040011, 24040012, 24080052, 24080053, 24080054, 24010010, 24010045, 24070081, 23110119, 24080048, 24040002, 24040001, 24040016, 24040015, 24060055, 24060089, 24080051, 23070031, 23070050, 23100050, 23100055, 23100059, 23100060, 23060001, 24010007, 24060060, 24060061, 24060090, 24050042, 24050043, 24050045, 24080059, 24050044, 24050027, 23070013, 23070036, 23070057, 23070058, 23120093, 23070023, 23070032, 23070033, 23070034, 23070035, 23070037, 23070038, 23070039, 23070040, 23070041, 23070043, 23070051, 23090077, 23090078, 23090079, 23090080, 23100031, 23100032, 23110156, 23120088, 23120089, 23120090, 23120119, 24010011, 24010012, 24010013, 24010014, 24010015, 24010016, 24060049, 24060086, 24060087, 24060088, 24060091, 24060052, 24010009, 22030040, 24010033, 24010035, 24010039, 24010040, 23090072, 23090073, 23090074, 23090075, 23090081, 23090082, 23090084, 23090086, 23090087, 23090088, 23090089, 23090090, 23100036, 23100037, 23100038, 23100039, 23100040, 23100041, 23100042, 23100043, 23100044, 23100045, 23120104, 23120074, 23120075, 23120076, 23120077, 23120078, 23120079, 23120080, 23120081, 23120082, 24010042, 24010043, 24010044, 24040004, 24040005, 24040006, 24040007, 24040018, 24040019, 24060053, 24060062, 24060063, 24060064, 24060083, 24060084, 24060085, 24060099, 24060100, 24060101, 24060102, 24060103, 24060104, 24060105, 24060106, 24060107, 24060108, 24060109, 24060129, 24060134, 24070067, 24070068, 24070069, 24070070, 24070071, 24070072, 24070073, 24070074, 24070075, 24070082, 24070083, 24070084, 24080016, 24080017, 24080024, 24080026, 23090064, 24040029, 24040030, 23060058, 23060059, 23060060, 23070001, 23070002, 23070004, 23070005, 23070006, 23110105, 23110116, 23110117, 23110118, 24080027, 24080028, 24080029, 24080030, 24060095, 24060096, 24060097, 24060071, 24090051, 24090057, 24090058, 24090059, 24090060, 24090066, 24090068, 24090072, 24090087, 24090088, 24040017, 24080047, 24040031, 24040032, 24040033, 24040034, 24040035, 24040036, 24040037, 24040038, 24040039, 24040040, 24040041, 24040042, 24040043, 24040044, 24040045, 24090069, 24090070, 24090073, 24090074, 24040014, 24050004, 24010031, 23120064, 23060029, 23060030, 23060041, 23060015, 23060028, 23070010, 23070014, 23070015, 23070007, 23070009, 23090068, 23090108, 23090109, 23090110, 23110121, 23110122, 23110123, 23110124, 23110125, 23110126, 23110127, 23110128, 23110129, 23110130, 23110131, 23110132, 23110133, 23110134, 23110135, 23110138, 23110139, 23110140, 23110141, 23110142, 23110143, 23110144, 23110145, 23110146, 23110147, 23110148, 23110149, 23110150, 23110179, 23110180, 24100066, 24100067, 24100068, 24100069, 24100070, 24100071, 24100072, 24100073, 24100074, 24100075, 24100076, 24100077, 24100078, 24100079, 24100080, 24100081, 24100082, 24100083, 24100084, 24100085, 24100057, 24100058, 24060072, 23110153, 23110154, 23110155, 24050002, 24080039, 24080055, 24080057, 24100064, 23110152, 24090056, 23110173, 24040025, 23120105, 21120226, 21120227, 24010003, 24010004, 24090061, 24090063, 23060052, 23060053, 23060054, 23120083, 23090065, 23090066, 23090063, 23110073, 24100087, 23060065, 23070018, 23090076, 23090061, 23090106, 23090119, 23110066, 23110074, 23110166, 23110171, 23110172, 23120120, 23120092, 23120073, 23120069, 23120071, 24040003, 24050020, 24080003, 24080004, 24080009, 24080010, 24080011, 24080012, 24080013, 24080014, 24080015, 24080005, 24080058, 24080060, 24090046, 23070019, 23110168, 23110169, 24040008, 23070021, 23070022, 24070076, 23110090, 23110151, 24040022, 24070096, 23110067, 22120059, 24060110, 24060111, 24060112, 24060113, 24060114, 24060115, 24060116, 24060117, 24060118, 24070046, 24070047, 24070048, 24070049, 24070050, 24070051, 24070052, 24070053, 24070054, 24070055, 24070056, 24070057, 24070058, 24070059, 24070060, 24070061, 24070062, 24070063, 24070064, 24070065, 24070066, 24060119, 24060120, 24060121, 24060122, 24060123, 24060124, 24060125, 24060126, 24060127, 24060128, 24060130, 24060131, 24060132, 24060133, 24060135, 24090064, 24090065, 24090077, 24090078, 23090067, 24010008, 24100086, 23110175, 23110177, 23110178, 24020007, 23110065, 23110061, 23110062, 23110063, 23110064, 23110091, 23110092, 23110093, 23110094, 23110095, 23110096, 23110097, 23110098, 23110099, 23110100, 23110101, 23110136, 23120084, 23120085, 23120086, 23120087, 23120066, 24050023, 24050024, 24050025, 24050007, 24050008, 24050009, 24050010, 24050011, 24050012, 24050013, 24050014, 24050015, 24050016, 24050017, 24050018, 24050019, 24060048, 24070085, 24070086, 24070087, 24070088, 24070089, 24070090, 24070091, 24070092, 24070093, 24070094, 24070095, 24080001, 24080002, 23030075, 24080049, 24080050, 24090047, 24090048, 24090049, 24090050, 24090052, 24090067, 24100088, 24100089, 24100090, 23110072, 23060064, 23070020, 23110106, 23110103, 23110104, 24010034, 24010032, 23090085, 24080018, 24080019, 24080020, 24080021, 24080022, 24080023, 23110080, 24090079, 24050021, 24050022, 23060050, 23100033, 23100034, 23100035, 23120091, 24060054, 24060058, 24060065, 24080031, 24080032, 24080033, 24080036, 24080037, 23120101, 23120102, 23070028, 23070029, 23070026, 23070027, 23090111, 24060059, 24080006, 23070030, 23120114, 24040023, 24040024, 24040027, 24040028, 23110170, 23070048, 23090091, 23090092, 23090093, 23090094, 23090095, 23090096, 23090098, 23090099, 23090101, 23090102, 23100046, 23100047, 23100048, 23100051, 23100052, 23100049, 23100053, 23100054, 23100056, 23100057, 23100058, 24050028, 24050029, 24050030, 24050031, 24050032, 24050033, 24050034, 24050035, 24050037, 24050038, 24050039, 24050040, 24050041, 24060098, 23090097, 24080046, 23060046, 23060047, 23060048, 23060049, 23060051, 23110089, 24060066, 24060067, 24070080, 24070100, 24070101, 24070102, 24070103, 24070104, 24070105, 23060061, 23060062, 23060066, 23060067, 23060068, 23060069, 23060070, 23060071, 23060072, 24090075, 23060073, 23120100, 24100065, 23070003, 23120094, 24060074, 24060075, 24060076, 24060077, 24060078, 24060079, 24060080, 24060081, 24060082, 24080044, 24080045, 24040026, 24080056, 24010002, 23120065, 23120070, 24010001, 24050006, 24050001, 24060051, 24070099, 23090107, 22090018, 23070008, 22090032, 23090112, 21050019, 23090103, 23090104, 23090117, 23090118, 23110076, 23110081, 23110082, 23110083, 23110085, 23110086, 21050020, 23120107, 23120118, 23120106, 23120108, 23120111, 23120061, 23120062, 23120063, 23120067, 23120068, 24010023, 24010024, 24010025, 24010026, 24010027, 24010028, 24010029, 24010030, 24010018, 24010019, 24010020, 24010021, 24010017, 24040013, 24090089, 24090090, 23070045, 23120096, 24050003, 24060069, 24060070, 24060073, 23110071, 24010041, 24090071, 24090076, 24090080, 24080008, 23070016, 23070017, 23120098, 23120103, 24060068, 23120097, 23070024, 23070044, 23110174, 23110165, 23120072, 24010005, 24050026, 24080007, 23110087, 21090133, 23090105, 23090120, 21080058, 21080063, 21080064, 21080066, 24060046, 24060047, 20100073, 23030089, 23060056, 23060057, 23110108, 23110109, 23110110, 23110111, 23110112, 23110113, 23110114, 23110115, 23110161, 23110162, 23110163, 23110164, 23120109, 23120110, 23120117, 24070097, 24070098, 23070042, 23070047, 23070053, 23070054, 23070055, 23070056, 23090069, 23090070, 23090071, 23090113, 23090114, 23090115, 23090116, 23110075, 23110157, 23110158, 23110159, 23110160, 23120095, 23120112, 23120113, 23120115, 24040020, 24040021, 24060056, 24060057, 24080040, 24080041, 24080042, 24080043, 24080035, 24080038, 24090081, 24090082, 24090083, 24090084, 24090085, 24090086, 21120248, 24100059, 24100060, 24100061, 24100062, 24100063, 24100052, 24100053, 24100054, 24100055, 24100056, 22120043, 22120042, 24010036, 23110078, 23110079, 23110088, 23120099, 23050038; \n2) UDI/DI 00850011479292, Serial Numbers: 21080057, 21080057, 22060024, 23060074, 21020045, 21110052, 21120094, 21020000, 21030107, 21040076, 21060109, 21070075, 20110013, 20110023, 20110158, 22040061, 23090062, 21030115, 21050024, 22030059, 21110051, 20100060, 21120090, 22090002; \n3) UDI-DI 00850011479308, Serial Numbers: 21120207, 20080089, 20100028, 22120047, 20100108, 22060025, 23110176, 23070060, 22120054, 23090100, 21120253, 22090095, 21040077, 21020015.", "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": "817 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" } } ] }