{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "140236", "product_res_number": "Z-0210-2016", "event_date_initiated": "2015-09-03", "event_date_posted": "2015-11-04", "recall_status": "Terminated", "event_date_terminated": "2016-01-22", "res_event_number": "72217", "product_code": "FLE", "k_numbers": [ "K111223" ], "product_description": "AMSCO 400 and AMSCO C Small Steam Sterilizers", "code_info": "Serial #'s: 033331205, 033341248, 033351210, 033401221, 033411215, 033451217, 030741306, 031491314, 032381302, 032341304, 033281222, 030621412, 030871412, 030871410, 031751401, 031771425, 031781412, 031781414, 031911436, R020141502, R020151501, R020191502, R020201501, R020261502, R020261504, R020271501, 030341514, R020471501, 030501540, 030651519, R021001503, R021051501", "firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "Ms. Kathryn E. Cadorette\n440-392-7231", "reason_for_recall": "In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadvertently prevents the capability to operate the foot pedal, which allows the Operator to open and close the sterilizer door.", "root_cause_description": "Software design", "action": "On 9/21/2015 the firm sent Recall Correction Notices to their customers.", "product_quantity": "32 units", "distribution_pattern": "US nationwide distribution.", "openfda": { "k_number": [ "K072087", "K050263", "K885140", "K926185", "K190062", "K893886", "K911322", "K173481", "K091731", "K213080", "K141009", "K223858", "K100622", "K233132", "K221227", "K191896", "K910778", "K833837", "K842631", "K243994", "K070657", "K103841", "K924596", "K964332", "K214057", "K221474", "K063711", "K962179", "K801309", "K962903", "K122625", "K233026", "K821591", "K021504", "K973550", "K063681", "K021223", "K192910", "K003441", "K970907", "K901147", "K924955", "K945117", "K163337", "K173490", "K093333", "K091136", "K991575", "K862495", "K921613", "K151597", "K850264", "K213758", "K250164", "K973225", "K033538", "K072466", "K111736", "K915054", "K222608", "K170228", "K994314", "K903613", "K852113", "K962755", "K201927", "K920478", "K030789", "K882465", "K183410", "K122774", "K213545", "K022816", "K953938", "K831356", "K090670", "K141879", "K252307", "K140736", "K210326", "K936181", "K213991", "K060337", "K232485", "K031259", "K844649", "K130172", "K903096", "K250168", "K874644", "K232658", "K830931", "K014174", "K792558", "K003470", "K233504", "K161848", "K954736", "K220736", "K951557", "K800080", "K890359", "K990189", "K982332", "K771229", "K082817", "K944036", "K111223", "K903614", "K112872", "K092490", "K120149", "K032192", "K910789", "K220102", "K870975", "K942989", "K122071", "K900432", "K211500", "K920293", "K173493", "K090783", "K173485", "K172159", "K023348", "K010865", "K823457", "K181456", "K951273", "K992744", "K112403", "K090339", "K090265", "K212424", "K962282", "K980014", "K243801", "K214120", "K895848", "K020590", "K961230", "K020747", "K112811", "K260254", "K170304", "K895275", "K180272", "K770536", "K910777", "K120441", "K213457", "K231489", "K882713", "K770682", "K954142", "K993856", "K024133", "K122978", "K210279", "K983679", "K132439", "K834152", "K112055", "K895638", "K910241", "K012573", "K203061", "K172825", "K143311", "K761032", "K181993", "K052532", "K041833", "K770372", "K021064", "K950341", "K852114", "K912471", "K261055", "K082435", "K781684", "K000077", "K911206", "K103504" ], "registration_number": [ "3010653034", "3010331645", "3012421607", "1825014", "1523530", "3013596742", "", "1932355", "3007279848", "3011683674", "3023861999", "8043629", "3011824442", "3001061128", "3013176080", "1219189", "3015542154", "9680353", "3011421558", "3005180920", "2916714", "3015376465", "3022516928", "2126663", "3008342949", "2435367", "3015207155", "9610612", "3002579136", "3016777357", "3018815412", "1220246", "3031563141", "3005899764", "3012068831", "3013300766", "3030597797", "3010446656", "3003934980", "3009519707", "1926681", "3005544459", "8030087", "3007515605", "1036362", "3016851379", "3010684578", "3038718579", "8010652", "3025308469", "3008110533", "2518157", "3027434168", "3035366890", "3044322716", "3006610845", "3009685834", "3003947740", "3015231789", "1017522", "3015729" ], "fei_number": [ "3010653034", "3010331645", "3012421607", "1825014", "1523530", "3013596742", "1841", "", "3007279848", "3011683674", "3023861999", "3011824442", "3001061128", "3013176080", "1000273801", "3008241044", "1219189", "3015542154", "3011421558", "3005180920", "2916714", "3015376465", "3022516928", "2126663", "2435367", "3015207155", "3002579136", "3016777357", "3018815412", "1220246", "1000119270", "3005899764", "3031563141", "3012068831", "3013300766", "3030597797", "3010446656", "3003934980", "3009519707", "1926681", "1036362", "3007515605", "3004097451", "3016851379", "3010684578", "3008342949", "3038718579", "3002806315", "3025308469", "3008110533", "2518157", "3027434168", "3035366890", "3044322716", "3006610845", "3009685834", "3003947740", "3015231789", "1017522", "3015729", "3005343391" ], "device_name": "Sterilizer, Steam", "medical_specialty_description": "General Hospital", "regulation_number": "880.6880", "device_class": "2" } } ] }