{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "105922", "product_res_number": "Z-0597-2012", "event_date_initiated": "2011-10-24", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2014-06-20", "res_event_number": "60456", "product_code": "FLE", "k_numbers": [ "K936181" ], "product_description": "Midmark M11 Ultra Steam Sterilizer, Distributed by: Midmark Corporation, 60 Vista Drive, Versailles, Ohio 45380.\n\nSterilize reusable equipment that is heat and moisture stable.", "code_info": "Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006", "firm_fei_number": "1523530", "recalling_firm": "Midmark Corportation", "address_1": "60 Vista Dr", "city": "Versailles", "state": "OH", "postal_code": "45380", "additional_info_contact": "937-526-8297", "reason_for_recall": "During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.", "root_cause_description": "Employee error", "action": "Midmark Corp. will begin sending customer communications out the week of January 9, 2012 to all affected customers. The letter will describe the product, problem, and actions to be taken by the customers. Additionally, a warning label and an illustration of where to place the label will be included with the letter. Customers may contact the firm at 1-800-643-6275.", "product_quantity": "30,255 units", "distribution_pattern": "Worldwide Distribution- USA (nationwide) including Puerto Rico and the countries of AUSTRALIA, BELGIUM, BRAZIL, CHILE, CHINA, EGYPT, FRANCE, GUAM, HONG KONG, HUNGARY, ICELAND, INDIA, KOREA, KUWAIT, MALAYSIA, MEXICO, NEW ZEALAND, POLAND, RUSSIA, SAIPAN MP, SAUDI ARABIA, SEOUL, SINGAPORE, TAIWAN, THAILAND, TURKEY, U.A.E., UNITED KINGDOM and WEST INDIES.", "openfda": { "k_number": [ "K012573", "K232485", "K103504", "K961230", "K903096", "K831356", "K911322", "K010865", "K082435", "K141879", "K953938", "K243801", "K103841", "K021064", "K090670", "K243994", "K132439", "K232658", "K862495", "K890359", "K882713", "K833837", "K903614", "K994314", "K770372", "K030789", "K100622", "K991575", "K771229", "K214057", "K090783", "K821591", "K945117", "K214120", "K233504", "K770536", "K063711", "K964332", "K122625", "K163337", "K022816", "K173490", "K800080", "K122071", "K962755", "K911206", "K885140", "K844649", "K903613", "K173485", "K792558", "K212424", "K982332", "K852114", "K882465", "K021223", "K112872", "K962179", "K210326", "K993856", "K962282", "K830931", "K973225", "K000077", "K210279", "K032192", "K823457", "K052532", "K203061", "K213991", "K173481", "K900432", "K912471", "K970907", "K874644", "K250164", "K920478", "K231489", "K920293", "K942989", "K213457", "K895275", "K926185", "K852113", "K233132", "K895848", "K990189", "K260254", "K021504", "K090265", "K936181", "K172825", "K143311", "K023348", "K082817", "K950341", "K140736", "K213080", "K220736", "K072466", "K221227", "K250168", "K910241", "K072087", "K973550", "K893886", "K252307", "K090339", "K091136", "K063681", "K122774", "K915054", "K191896", "K112403", "K834152", "K842631", "K901147", "K770682", "K870975", "K924955", "K122978", "K213758", "K980014", "K111223", "K221474", "K041833", "K060337", "K261055", "K192910", "K233026", "K781684", "K111736", "K954736", "K161848", "K201927", "K910777", "K031259", "K181456", "K130172", "K954142", "K223858", "K092490", "K120149", "K951557", "K141009", "K170304", "K910778", "K962903", "K093333", "K921613", "K070657", "K112055", "K091731", "K033538", "K020747", "K024133", "K761032", "K181993", "K924596", "K020590", "K183410", "K895638", "K910789", "K151597", "K211500", "K014174", "K003441", "K120441", "K951273", "K050263", "K992744", "K112811", "K190062", "K944036", "K850264", "K983679", "K180272", "K170228", "K220102", "K801309", "K213545", "K173493", "K172159", "K222608", "K003470" ], "device_name": "Sterilizer, Steam", "medical_specialty_description": "General Hospital", "regulation_number": "880.6880", "device_class": "2", "registration_number": [ "3010446656", "3002579136", "3011824442", "3007515605", "3016851379", "3011683674", "3006610845", "3009685834", "2435367", "", "3003934980", "3008342949", "3015376465", "3010684578", "9610612", "3005544459", "3010653034", "3031563141", "3005899764", "1932355", "1219189", "2126663", "8010652", "3007279848", "3003947740", "3035366890", "3012421607", "1036362", "3013596742", "2518157", "1017522", "3013176080", "1523530", "3044322716", "3008110533", "3012068831", "3015231789", "3015207155", "3011421558", "3001061128", "3018815412", "3005180920", "3010331645", "3015542154", "2916714", "3015729", "8030087", "1926681", "3030597797", "3027434168", "3025308469", "8043629", "3013300766", "3009519707", "9680353", "1825014", "3038718579", "1220246", "3016777357", "3022516928", "3023861999" ], "fei_number": [ "3010446656", "3002579136", "3011824442", "3007515605", "3016851379", "3011683674", "3006610845", "3009685834", "2435367", "", "3003934980", "3008342949", "3015376465", "3010684578", "1000119270", "3010653034", "3031563141", "1841", "3005899764", "1219189", "2126663", "3007279848", "3003947740", "3035366890", "3012421607", "1000273801", "1036362", "2518157", "3013596742", "1017522", "3013176080", "1523530", "3044322716", "3002806315", "3008110533", "3008241044", "3012068831", "3015231789", "3015207155", "3011421558", "3001061128", "3018815412", "3005180920", "3010331645", "3015542154", "2916714", "3015729", "1926681", "3030597797", "3027434168", "3025308469", "3013300766", "3004097451", "3009519707", "3005343391", "1825014", "3038718579", "1220246", "3016777357", "3022516928", "3023861999" ] } } ] }