{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "188668", "product_res_number": "Z-2448-2021", "event_date_initiated": "2021-07-14", "event_date_created": "2021-09-10", "recall_status": "Open, Classified", "res_event_number": "88440", "product_code": "FDF", "k_numbers": [ "K131855", "K181084", "K210485" ], "product_description": "Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel \nModels:\nEC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L;\n\nColonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel\nModel: EC-3890TLK", "code_info": "All devices distributed by Pentax in the US between April 2014 and May 2021", "firm_fei_number": "1000080301", "recalling_firm": "Pentax of America Inc", "address_1": "3 Paragon Dr", "city": "Montvale", "state": "NJ", "postal_code": "07645-1782", "additional_info_contact": "973-628-2199", "reason_for_recall": "Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families", "root_cause_description": "Device Design", "action": "Pentax issued Urgent Medical Device Correction letter via UPS mailing on 7/14/21. \nLetter states reason for recall, health risk and action to take (USB drive along with the enclosed instruction sheet enclosed).\n Letter states:\nPENTAX separated the EC and EG rIFUs into 5 separate rIFUs .\n The grouping will allow the following for reprocessing personnel:\n\" Eliminate the need to identify optional configurations of instrument channels and water jet channels\n\" Simplify the instructions and graphics in the individual rIFUs\nPlease replace any previous versions of rIFUs with the most current revision. Please note that this documentation set is current as of this date. For future updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com.\nCustomer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at customeradvisories@pentaxmedical.com.\n\nQuestions regarding this action, please feel free to contact us at:\no Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST)\no Fax: 201-799-4063 (alternate 201-391-4189)\no Email: customeradvisories@pentaxmedical.com", "product_quantity": "28849 units Total", "distribution_pattern": "Nationwide", "openfda": { "k_number": [ "K103312", "K162622", "K190669", "K242325", "K182540", "K070330", "K173392", "K232922", "K810791", "K130718", "K252457", "K951580", "K112391", "K243261", "K191220", "K221452", "K230588", "K790338", "K884857", "K161355", "K192793", "K063654", "K192664", "K153483", "K160015", "K131855", "K160196", "K232043", "K261587", "K141286", "K261015", "K051068", "K223827", "K173085", "K111028", "K051541", "K220158", "K801223", "K260503", "K951575", "K163492", "K822846", "K192588", "K080317", "K143732", "K043487", "K181437", "K951578", "K111756", "K210981", "K132839", "K180285", "K070622", "K112680", "K090116", "K760452", "K954704", "K131780", "K901610", "K113050", "K091783", "K101053", "K041903", "K943895", "K213773", "K250432", "K081004", "K202469", "K810682", "K083180", "K162330", "K120289", "K190649", "K210851", "K810654", "K063585", "K171673", "K132210", "K211819", "K213578", "K231254", "K100624", "K160356", "K141598", "K102616", "K951579", "K961570", "K001241", "K140595", "K093187", "K093037", "K100966", "K961563", "K242110", "K951574", "K260423", "K792179", "K210052", "K101191", "K032688", "K121582", "K244029", "K091305", "K970372", "K173317", "K220007", "K180405", "K023259", "K162428", "K230332", "K181084", "K002749", "K161791", "K052930", "K172036" ], "registration_number": [ "3004016520", "3010703925", "9611112", "3010707607", "3011193403", "3023102955", "3005099803", "3010288205", "3042225166", "3015746529", "3021246306", "3006161756", "3011050570", "3012843412", "3018258446", "3015451828", "3011416394", "3014769442", "3002808022", "3028058843", "2528981", "3013023255", "9610595", "9610617", "9616684", "8010047", "3002807314", "1047843", "3004052101", "2246552", "3044545674", "3009420598", "3003637092", "1528319", "3008797804", "3013944123", "3008879776", "3022106566", "3017210488", "3001722928", "3020707080", "3008386005", "9681260", "3004111573", "3015136743", "3004644065", "1651395", "3012414760", "2950776", "1222928", "3015525240", "3009698186", "3013505983", "3010202439", "3003775006", "3006546082", "3024021261", "1220477", "3010390468", "9614641", "3002808148", "9611680", "3021008900", "3014279513", "3014605202", "3014342096", "3011816755", "3013184907", "3042172882", "3005261802", "9610877", "3005814162", "3010009693", "2020550", "3003782610", "3004705634", "1000121056", "1221826", "2011171", "3010229237" ], "fei_number": [ "3004016520", "3010703925", "3010707607", "3011193403", "3023102955", "3005099803", "3010288205", "3042225166", "3015746529", "3021246306", "3002964398", "3011050570", "3012843412", "3018258446", "1000135740", "3002806565", "3015451828", "3011416394", "3014769442", "3002808022", "3028058843", "3002807969", "2528981", "3013023255", "1000122656", "1000120613", "3002807314", "1047843", "3004052101", "3002808127", "2246552", "3044545674", "3009420598", "3003637092", "3008797804", "3013944123", "3008879776", "3022106566", "3017210488", "3001722928", "3020707080", "3008386005", "3004111573", "3003995201", "3003012447", "3015136743", "3004644065", "3012414760", "3007475226", "3009698186", "3013505983", "3015525240", "3008782585", "3003775006", "3006546082", "3024021261", "1220477", "3008185830", "3010390468", "3002808148", "3021008900", "3002808268", "3014279513", "3014605202", "3014342096", "3011816755", "3013184907", "3042172882", "3005261802", "3005814162", "3010009693", "2020550", "3003782610", "3004705634", "3002807795", "1000121056", "1221826", "2011171", "3002913962", "3010229237" ], "device_name": "Colonoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }