{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 8 } }, "results": [ { "cfres_id": "214144", "product_res_number": "Z-2139-2025", "event_date_initiated": "2025-06-18", "event_date_posted": "2025-07-21", "recall_status": "Open, Classified", "res_event_number": "96982", "product_code": "HIH", "k_numbers": [ "K890328" ], "product_description": "Blue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. \r\n\r\nThe reusable silicone seals fit over the biopsy port of endoscopes to seal off the working channel. Some contain a lumen which allows instruments to be passed through the seal and minimize or prevent fluid leakage during endoscopic procedures.", "code_info": "Model Number: CS-B612. UDI-DI: 00821925038318, 00821925001176. All lot numbers", "firm_fei_number": "2429304", "recalling_firm": "Olympus Corporation of the Americas", "address_1": "3500 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8229", "additional_info_contact": "Cynthia Ow\n647-9993203", "reason_for_recall": "Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).", "root_cause_description": "Packaging change control", "action": "Olympus notified consignees on about 06/18/2025 via letter. Consignees were instructed to review the notification and arrange for the return of all affected units on hand, ensure all affected personnel are aware, and notify customers if the affected units were further distributed. Olympus also requested that consignees complete and return the response form acknowledging receipt of the notification.", "product_quantity": "19 units", "distribution_pattern": "International distribution to the country of Japan.", "openfda": { "k_number": [ "K952032", "K880314", "K962482", "K103389", "K132015", "K192822", "K992027", "K190639", "K091838", "K132384", "K182006", "K202445", "K955119", "K991563", "K152143", "K952186", "K213207", "K953109", "K091100", "K120593", "K122563", "K223520", "K211227", "K897003", "K950055", "K071127", "K972426", "K922711", "K172566", "K040302", "K983901", "K983569", "K131736", "K160751", "K254251", "K895857", "K182975", "K812202", "K971420", "K791330", "K012869", "K962271", "K260984", "K141515", "K191281", "K170660", "K931764", "K961688", "K110038", "K253020", "K892390", "K150158", "K213171", "K223813", "K240401", "K940316", "K982771", "K191538", "K022445", "K102686", "K254050", "K053583", "K121868", "K914108", "K073690", "K192811", "K000673", "K190113", "K173070", "K180496", "K241987", "K190797", "K961506", "K905392", "K123151", "K232003", "K921942", "K982738", "K001740", "K231260", "K974297", "K841825", "K971188", "K191958", "K994418", "K240978", "K031974", "K903146", "K982659", "K252793", "K951946", "K091465", "K233635", "K934286", "K191335", "K962256", "K093218", "K233500", "K142029", "K891451", "K971374", "K952033", "K180096", "K193007", "K961605", "K980302", "K200038", "K981828", "K882761", "K954164", "K013870", "K881249", "K161763", "K003802", "K223885", "K192278", "K171113", "K190372", "K151275", "K152723", "K950036", "K180752", "K924631", "K173901", "K192100", "K990910", "K811270", "K981800", "K040390", "K201970", "K992901", "K890328", "K882270", "K092421", "K954488", "K971305", "K935716", "K243382", "K041774", "K181974", "K993749", "K252012", "K033113", "K100559", "K922420", "K810569", "K181545", "K112134", "K031787", "K954648", "K160510", "K990411", "K183020", "K933544", "K896917", "K945265", "K092278", "K182675", "K081070", "K201756", "K221557", "K971518", "K952779", "K123330", "K131581", "K972210", "K931994", "K022480", "K950255", "K190827", "K254294", "K210270", "K122498" ], "registration_number": [ "1650907", "3006131984", "2242464", "3016678045", "3017616393", "9515015", "3016904853", "3012494290", "3015139943", "3042158861", "3011459664", "3025482817", "1649518", "2936485", "9710641", "1047843", "2953359", "3023365313", "8010510", "3027454635", "3007156625", "3010132111", "1219930", "9611503", "3035710892", "9614434", "3015042209", "9681753", "3007789561", "3014615697", "3040391040", "3030153385", "3010707607", "3011986317", "8010418", "3012263546", "3030733800", "9710457", "3007200016", "3010273872", "1222780", "3002907620", "3011011193", "3003990090", "2183744", "1225798", "1221485", "1222313", "3010399422", "3015142721", "3035387162", "2243757", "3043226252", "3016667340", "3007699067", "3004784537", "3033902430", "8010047", "3015219237", "3009350690", "8010349", "9680001", "1320894", "3003724334", "3009746061", "3013247477", "1223490", "3009217531", "9612074", "3004111573", "1418479", "1056128", "1319639", "3002808148", "1216677", "3013944123", "3043236281", "2085947", "3008693678", "3006787036", "3014342096", "8043903", "3014644276", "1064858", "9610595", "3000279801", "9610773", "9610617", "3003790304", "3014279513", "3003542872", "2954783", "9611102", "1643817", "3008494403", "1220477", "3021023673", "3013557562", "3007113251", "3035781529", "8010877", "3007960282", "3011050570", "1221826", "3015972753", "3012322232", "3021246306", "3015512350", "3011543740", "2245304", "3021632375", "3006330030", "1519132", "9680515", "3007829657", "2020550", "9680718", "3024021261", "3009420598", "3014461810", "3004361445", "3021610866", "9611612", "2244478", "3008837339", "3002807310", "3029929134", "3008386005", "3018094310", "9617070", "3014407293", "3012356141", "3010202439", "3006546082", "3015976667", "3028536560" ], "fei_number": [ "3006131984", "3000219468", "3016678045", "2242464", "1000138054", "3017616393", "3003565456", "3016904853", "3000215205", "3002807072", "3012494290", "3015139943", "3042158861", "3000303338", "3011459664", "3025482817", "2936485", "1047843", "3008397795", "3023365313", "3027454635", "3010132111", "1219930", "3003186357", "3035710892", "3015042209", "3007789561", "3008133910", "3002808445", "3002807134", "3014615697", "3040391040", "3030153385", "3010707607", "3003276727", "3011986317", "3012263546", "3030733800", "1000121050", "3007200016", "3010273872", "3001236277", "3002808088", "3002907620", "3011011193", "1000136543", "1000120743", "3003990090", "2183744", "1221485", "3010399422", "3015142721", "3035387162", "3001451571", "3003058840", "2243757", "3043226252", "3016667340", "3007699067", "3004784537", "3033902430", "3002807795", "3015219237", "3942", "3009350690", "3003724334", "3009746061", "3002808273", "3013247477", "3009217531", "3002808001", "3004111573", "1418479", "1216677", "3002808148", "3013944123", "3043236281", "1000132435", "3002808268", "3002807847", "3008693678", "3006787036", "3014342096", "3000279801", "3005969827", "3003790304", "3002681132", "3014279513", "3003542872", "1643817", "3008494403", "3007130719", "1220477", "3021023673", "3013557562", "3001595430", "3007475226", "3007113251", "3035781529", "3007960282", "3000226659", "3011050570", "1221826", "3015972753", "3012322232", "3000280067", "3021246306", "3015512350", "3011543740", "2245304", "3002964398", "3021632375", "3006330030", "1519132", "3006149253", "3002808335", "3007829657", "2020550", "3000204191", "3024021261", "3009420598", "3014461810", "3004361445", "3021610866", "1000136269", "3008837339", "3002807310", "3029929134", "3008386005", "3018094310", "3014407293", "3012356141", "3002807798", "3006546082", "3015976667", "3028536560" ], "device_name": "Hysteroscope (And Accessories)", "medical_specialty_description": "Obstetrics/Gynecology", "regulation_number": "884.1690", "device_class": "2" } } ] }