{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189120", "product_res_number": "Z-0121-2022", "event_date_initiated": "2021-08-19", "event_date_created": "2021-10-16", "recall_status": "Open, Classified", "res_event_number": "88628", "product_code": "FLE", "k_numbers": [ "K141009" ], "product_description": "P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641", "code_info": "Model number: P2131; NSN: 6530-01-641-4641; Serial Numbers AFS-0001 through AFS-0386. Note: AFS-0297 was not manufactured.", "firm_fei_number": "3011421558", "recalling_firm": "Fort Defiance Industries, LLC", "address_1": "2411 Maremont Pkwy", "city": "Loudon", "state": "TN", "postal_code": "37774-1066", "additional_info_contact": "865-408-0100", "reason_for_recall": "The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.", "root_cause_description": "Device Design", "action": "A Recall notification letter titled, \"MEDICAL DEVICE ADVISORY NOTICE\" was sent to consignees on 08/19/2021 via a email. The notice provides instructions regarding continued use of the device until FDI provides a protective cover for the rear heater plate and cover assembly. It mentions, \"THE OPERATOR SHOULD NOT TOUCH THE REAR HEATER PLATE AND COVER ASSEMBLY OF THE DEVICE WHILE THE DEVICE IS IN USE OR POWERED ON. IF ACCESS TO THE REAR OF THE DEVICE IS REQUIRED, PLEASE TURN THE POWER OF THE UNIT OFF USING THE FRONT PANEL SWITCH OR DISCONNECT INCOMING POWER TO THE DEVICE. DO NOT ATTEMPT TO MODIFY THE DEVICE TO CHANGE THE ELECTRICAL GROUND CONDITION OF THE HEATER PLATE AND COVER ASSEMBLY AS THIS WILL IMPACT DEVICE PERFORMANCE.\"", "product_quantity": "380 devices", "distribution_pattern": "Distributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally to Canada.", "openfda": { "k_number": [ "K172159", "K072466", "K031259", "K770372", "K191896", "K122978", "K771229", "K214120", "K911206", "K210326", "K910777", "K921613", "K924955", "K122774", "K030789", "K895848", "K170228", "K770682", "K163337", "K112055", "K964332", "K003441", "K173481", "K180272", "K221227", "K792558", "K953938", "K903096", "K910241", "K213457", "K915054", "K232658", "K143311", "K010865", "K950341", "K120149", "K151597", "K993856", "K903613", "K882713", "K161848", "K050263", "K944036", "K063681", "K041833", "K223858", "K173493", "K912471", "K122625", "K243801", "K082435", "K961230", "K213758", "K900432", "K942989", "K833837", "K962282", "K033538", "K895638", "K834152", "K032192", "K901147", "K842631", "K112872", "K000077", "K954142", "K213545", "K214057", "K243994", "K893886", "K220102", "K232485", "K951557", "K103841", "K082817", "K103504", "K990189", "K173485", "K910789", "K831356", "K962903", "K233132", "K112403", "K020590", "K951273", "K973225", "K022816", "K870975", "K823457", "K111223", "K994314", "K945117", "K911322", "K954736", "K920293", "K012573", "K181456", "K261055", "K090783", "K140736", "K120441", "K211500", "K203061", "K052532", "K210279", "K070657", "K093333", "K903614", "K850264", "K100622", "K926185", "K761032", "K172825", "K213080", "K992744", "K982332", "K260254", "K801309", "K090339", "K890359", "K021064", "K170304", "K920478", "K781684", "K091731", "K020747", "K821591", "K233504", "K183410", "K014174", "K231489", "K973550", "K874644", "K063711", "K962179", "K213991", "K141879", "K181993", "K250164", "K862495", "K800080", "K141009", "K021223", "K222608", "K132439", "K250168", "K111736", "K970907", "K190062", "K885140", "K091136", "K844649", "K924596", "K252307", "K882465", "K130172", "K852114", "K003470", "K830931", "K072087", "K221474", "K983679", "K021504", "K201927", "K060337", "K090670", "K910778", "K212424", "K936181", "K991575", "K023348", "K112811", "K220736", "K024133", "K122071", "K895275", "K852113", "K090265", "K192910", "K770536", "K980014", "K173490", "K962755", "K233026", "K092490" ], "device_name": "Sterilizer, Steam", "medical_specialty_description": "General Hospital", "regulation_number": "880.6880", "device_class": "2", "registration_number": [ "3027434168", "", "2518157", "3015729", "1036362", "3001061128", "1523530", "8010652", "9610612", "3007515605", "3010446656", "3018815412", "3007279848", "3013596742", "8030087", "3003934980", "3009685834", "3009519707", "3015231789", "3010684578", "9680353", "3023861999", "3012068831", "3035366890", "3031563141", "1219189", "3022516928", "3015376465", "3003947740", "3015542154", "3016851379", "3011824442", "3025308469", "2916714", "3010653034", "3006610845", "3012421607", "1926681", "2126663", "8043629", "3013300766", "1017522", "2435367", "3002579136", "3008110533", "3016777357", "3011421558", "3005180920", "3013176080", "3005899764", "1220246", "3038718579", "3011683674", "3008342949", "3030597797", "3015207155", "3010331645", "3005544459", "1825014", "3044322716", "1932355" ], "fei_number": [ "3027434168", "", "2518157", "3015729", "1036362", "3001061128", "1523530", "3007515605", "3010446656", "3018815412", "3007279848", "3013596742", "3003934980", "3009685834", "3009519707", "3010684578", "3023861999", "3012068831", "3035366890", "3031563141", "1000273801", "1219189", "3022516928", "3005343391", "3015376465", "3003947740", "3016851379", "3015542154", "3011824442", "3025308469", "3004097451", "3010653034", "3006610845", "2916714", "3012421607", "3002806315", "1926681", "2126663", "3013300766", "1017522", "3008241044", "3002579136", "3008110533", "3016777357", "3011421558", "2435367", "3005180920", "3013176080", "3005899764", "1220246", "3038718579", "3011683674", "1000119270", "3008342949", "3030597797", "3015207155", "3010331645", "1841", "1825014", "3044322716", "3015231789" ] } } ] }