{ "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": 1 } }, "results": [ { "cfres_id": "221436", "product_res_number": "Z-2983-2026", "event_date_initiated": "2026-07-08", "event_date_posted": "2026-08-18", "recall_status": "Open, Classified", "res_event_number": "99371", "product_code": "FLE", "k_numbers": [ "K141009" ], "product_description": "Fort Defiance Industries (FDI), Automated Field Steam Sterilizer\nREF: P2131", "code_info": "Lot Code: All serial numbers/\n\nGTIN: (01) 00862992000327", "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": "L. Chris Coleman\n+1-865-6576108", "reason_for_recall": "The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.", "root_cause_description": "Component design/selection", "action": "Between the dates of July 8, 2026 - July 16, 2026 Fort Defiance Industries (FDI) issued a Urgent Medical Device Recall to affected consignees vi Email. FDI ask consignees to take the following actions:\n\n1.\tDevices can continue in operation until the fix is implemented.\n2.\tIn the interim, users should avoid touching the WRS power connector during operation as a precaution.\n3.\tPlease contact FDI and order the upgrade kit complete with instructions to perform this Field Correction. \n4.\tAfter receiving the kit, please review the instructions and determine if you are competent to perform the update. The instructions will state alternate options to complete the repair (i.e. send to military depot).\n5.\tPerform the repair\n6.\tFDI requests a phone call or e-mail confirmation when the upgrade is completed. This confirmation can be a phone call or e-mail message.", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MD, VA, NJ, TN and the countries of Canada, Lithuania, Spain.", "openfda": { "k_number": [ "K022816", "K170228", "K213758", "K030789", "K024133", "K231489", "K983679", "K140736", "K964332", "K010865", "K920478", "K990189", "K143311", "K020590", "K173485", "K991575", "K243994", "K900432", "K250168", "K170304", "K111223", "K994314", "K190062", "K221227", "K252307", "K021223", "K103841", "K023348", "K903096", "K903613", "K261055", "K172825", "K910778", "K926185", "K950341", "K890359", "K091731", "K911206", "K213457", "K993856", "K232658", "K112872", "K220736", "K982332", "K936181", "K980014", "K260254", "K910777", "K951557", "K203061", "K141009", "K223858", "K173490", "K082817", "K973550", "K771229", "K012573", "K100622", "K214120", "K141879", "K232485", "K120149", "K020747", "K122625", "K912471", "K090265", "K862495", "K213991", "K895638", "K874644", "K213545", "K901147", "K091136", "K954142", "K882713", "K130172", "K221474", "K021504", "K823457", "K111736", "K210326", "K945117", "K834152", "K895848", "K893886", "K213080", "K183410", "K082435", "K821591", "K173481", "K954736", "K181993", "K910789", "K052532", "K122774", "K852113", "K122071", "K924596", "K000077", "K243801", "K132439", "K944036", "K801309", "K924955", "K831356", "K844649", "K962903", "K921613", "K212424", "K850264", "K181456", "K973225", "K122978", "K191896", "K072466", "K222608", "K112055", "K792558", "K090339", "K003441", "K233026", "K852114", "K951273", "K970907", "K233504", "K770536", "K885140", "K060337", "K870975", "K250164", "K161848", "K063711", "K842631", "K003470", "K910241", "K770372", "K151597", "K072087", "K962282", "K120441", "K090670", "K021064", "K961230", "K915054", "K092490", "K103504", "K911322", "K833837", "K050263", "K173493", "K953938", "K770682", "K214057", "K903614", "K180272", "K172159", "K233132", "K962179", "K063681", "K895275", "K882465", "K112811", "K942989", "K992744", "K031259", "K014174", "K032192", "K781684", "K041833", "K163337", "K962755", "K800080", "K090783", "K830931", "K093333", "K210279", "K112403", "K192910", "K201927", "K920293", "K070657", "K211500", "K761032", "K033538", "K220102" ], "device_name": "Sterilizer, Steam", "medical_specialty_description": "General Hospital", "regulation_number": "880.6880", "device_class": "2", "registration_number": [ "", "3002579136", "3009519707", "3005544459", "3013176080", "3007515605", "3031563141", "3011421558", "1017522", "3027434168", "3003934980", "8030087", "3015376465", "3005899764", "3009685834", "9610612", "3044322716", "3008110533", "3001061128", "2435367", "3012068831", "2518157", "3022516928", "3030597797", "3023861999", "3013300766", "3015542154", "3012421607", "1825014", "3015729", "1036362", "3006610845", "3007279848", "1932355", "9680353", "3008342949", "1523530", "1220246", "2126663", "3013596742", "3035366890", "3016777357", "1219189", "3010446656", "8010652", "3015207155", "3010684578", "3038718579", "2916714", "3003947740", "1926681", "3005180920", "3018815412", "3010653034", "3011824442", "3025308469", "8043629", "3015231789", "3011683674", "3010331645", "3016851379" ], "fei_number": [ "", "3002579136", "3009519707", "3013176080", "3007515605", "3031563141", "3011421558", "1017522", "3027434168", "3003934980", "3015376465", "3005899764", "3009685834", "3044322716", "3008110533", "3001061128", "2435367", "3012068831", "3004097451", "2518157", "3022516928", "3030597797", "3023861999", "3013300766", "3015542154", "3012421607", "1825014", "3015729", "1036362", "1000119270", "3006610845", "3007279848", "3008342949", "1841", "1523530", "1220246", "2126663", "3013596742", "3035366890", "3008241044", "3016777357", "3002806315", "1219189", "3010446656", "3015207155", "3010684578", "3038718579", "2916714", "3003947740", "1926681", "3005180920", "3018815412", "3010653034", "3005343391", "3011824442", "1000273801", "3025308469", "3015231789", "3011683674", "3010331645", "3016851379" ] } } ] }