{ "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": "124585", "product_res_number": "Z-0605-2014", "event_date_initiated": "2013-09-10", "event_date_posted": "2013-12-28", "recall_status": "Terminated", "event_date_terminated": "2014-02-14", "res_event_number": "67036", "product_code": "FRC", "k_numbers": [ "K083665", "K854631", "K854902" ], "product_description": "VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH.\r\n\r\nIntended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.", "code_info": "Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.", "firm_fei_number": "1527821", "recalling_firm": "Steris Corporation", "address_1": "5960 Heisley Rd", "city": "Mentor", "state": "OH", "postal_code": "44060-1834", "additional_info_contact": "440-392-7601", "reason_for_recall": "STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved.", "root_cause_description": "Use error", "action": "On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.", "product_quantity": "1,238 boxes", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.", "openfda": { "k_number": [ "K910417", "K173670", "K050664", "K193154", "K172748", "K233681", "K925745", "K090569", "K140589", "K203560", "K822024", "K891366", "K092755", "K172752", "K960777", "K192550", "K022706", "K123546", "K872867", "K183300", "K173519", "K223023", "K233814", "K902344", "K152060", "K073618", "K170427", "K202721", "K051173", "K020026", "K071014", "K923739", "K251452", "K031012", "K122044", "K141580", "K242453", "K171504", "K200996", "K961721", "K850144", "K223717", "K852192", "K884615", "K221641", "K004009", "K091950", "K170070", "K092944", "K041099", "K133322", "K111515", "K770953", "K173584", "K111391", "K962441", "K090514", "K042450", "K031226", "K122362", "K991675", "K854902", "K123017", "K930682", "K801678", "K900771", "K191021", "K073244", "K051643", "K141238", "K171287", "K200092", "K103222", "K173488", "K202879", "K243501", "K771132", "K252680", "K141312", "K241710", "K241542", "K844479", "K250061", "K925496", "K092906", "K771080", "K241959", "K121484", "K140708", "K151482", "K994381", "K133549", "K841583", "K905425", "K051056", "K071537", "K173633", "K121593", "K922212", "K211705", "K113302", "K260766", "K912796", "K200766", "K240717", "K103321", "K173626", "K173435", "K192025", "K971432", "K140392", "K930683", "K890754", "K070595", "K173629", "K041386", "K083665", "K122024", "K863122", "K812272", "K210277", "K163646", "K170039", "K212193", "K792648", "K172432", "K800482", "K101910", "K160546", "K223715", "K926364", "K832922", "K140620", "K884767", "K894399", "K855120", "K994055", "K113221", "K213881", "K250044", "K960790", "K102884", "K854631", "K200536", "K151971", "K971430", "K024079", "K020205", "K171003", "K963841", "K792649", "K993775", "K082756", "K895704", "K141244", "K130263", "K981497", "K200126", "K112018", "K192980", "K231383", "K183294", "K023716", "K921909", "K800029", "K140499", "K802228", "K181686", "K182404", "K032723", "K242538", "K231490", "K103277", "K181434", "K111150", "K891784", "K220473", "K032914", "K810930", "K181429", "K972747", "K173437", "K173634", "K251122", "K213809", "K894398", "K200970", "K163144", "K841709", "K855101", "K050591", "K171587", "K190297", "K172474", "K192001", "K133267", "K761015", "K041784", "K213296", "K111375", "K182931", "K991618", "K093794", "K151585", "K052128", "K903024" ], "registration_number": [ "3030733800", "8030087", "3042272797", "2432141", "3012494290", "3012421607", "3013298431", "3011061109", "3036504234", "3012723641", "3015392401", "3003476474", "3043226252", "2434982", "1416605", "2029076", "2028456", "3013145340", "1720309", "3031757047", "3004080920", "3009609218", "9611959", "3004634710", "3017524825", "2133641", "3038718579", "3016075971", "3014421917", "3016678045", "2410251", "1319130", "2084725", "2183301", "3008925937", "3009968482", "3013557562", "3000251274", "3030626857", "3014579161", "3013667284", "3007412809", "3031841433" ], "fei_number": [ "3030733800", "1000125215", "3042272797", "2432141", "3012494290", "3012421607", "3013298431", "3011061109", "3002677549", "3036504234", "3015392401", "1000160630", "3003476474", "3043226252", "2434982", "1416605", "3003662624", "3013145340", "1720309", "3031757047", "3000203466", "3004080920", "3009609218", "3005343391", "3004634710", "3017524825", "3038718579", "3016075971", "3014421917", "3016678045", "2410251", "1319130", "2183301", "3008925937", "3009968482", "3013557562", "3000251274", "3030626857", "3014579161", "3014534", "3013667284", "3007412809", "3031841433" ], "device_name": "Indicator, Biological Sterilization Process", "medical_specialty_description": "General Hospital", "regulation_number": "880.2800", "device_class": "2" } } ] }