{ "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": "184493", "product_res_number": "Z-0648-2021", "event_date_initiated": "2020-11-03", "event_date_created": "2020-12-18", "recall_status": "Terminated", "event_date_terminated": "2021-09-03", "res_event_number": "86763", "product_code": "OCX", "k_numbers": [ "K181509", "K182998" ], "product_description": "ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof Corporation, 393 Sagamore Avenue, Mineola, NY 11501\n\nProduct Code: 345SVVO1", "code_info": "Lot Numbers: 19122414, 20030401, 20030402 Unit UDI: 0810929040380 Box UDI:\t10810929040387\t Carton Box UDI: 20810929040384", "firm_fei_number": "3014749926", "recalling_firm": "GA HEALTH COMPANY LIMITED", "address_1": "Unit 18, 21/F 2 n.t. hong kong sar on yiu street", "address_2": "Unit 18 21/F", "city": "Shatin", "state": "N.T", "reason_for_recall": "Suction button is reported sticky and/or broken during or after the procedure, may cause prolonged procedure", "root_cause_description": "Process control", "action": "GA Health Company Limited ( referred to as GA Health) issued URGENT: MEDICAL DEVICE RECALL notification letters is sent to affected direct consignees via email on 11/3/20 . The letter sent together with Recall Notice to Physician and Acknowledgement and Receipt Form which allows direct consignee to distribute to customer and collects feedback from direct consignee respectively. \n\nActions to be Taken by the Distributor\nTo facilitate quarantine of affected lots, GA Health recommends the following:\n\" Review the device model and lot number below to identify and quarantine stock remained in your warehouse.\n\nSend the Recall Notice to Physician if you have already distributed the device to hospitals or clinics.\n\" Return the Acknowledgement and Receipt Form to us within 7 calendar days upon receipt of this letter.\n\" Discard the affected stock in you and your customers warehouse. Have the customers return any affected product to you, discard it also in your warehouse within 30 days upon receipt of this letter.\n\" To discard the product, complete the enclosed RMA Form and complete scrap declaration. Return these two documents to your GA Health sales representative at lewis@gahealth.net within 30 days upon receipt of this letter. This will allow us to document the amount of product you will scrap for follow up arrangement.\n\nShould you have questions about this issue, contact lewis@gahealth.net or by phone at +852 2833 9010.", "product_quantity": "100,000 units", "distribution_pattern": "US Nationwide distribution including in the states of IL,NY, NJ, WI, MI, MN, WI.", "openfda": { "k_number": [ "K222173", "K122417", "K030765", "K230773", "K760451", "K203350", "K021776", "K122740", "K191366", "K231602", "K822061", "K230932", "K202560", "K181418", "K241874", "K182319", "K220785", "K251997", "K182444", "K231418", "K152140", "K131426", "K181457", "K200479", "K833331", "K221824", "K222695", "K103235", "K031457", "K241704", "K242357", "K191438", "K020614", "K182998", "K242134", "K233442", "K844691", "K103239", "K140315", "K231471", "K142068", "K832009", "K060962", "K193250", "K223171", "K092461", "K193036", "K173758", "K903834", "K931201", "K905102", "K181509", "K992535", "K161167", "K113119", "K132776", "K251986", "K111274", "K221310", "K971125", "K993778", "K182275", "K891339", "K140753", "K942918", "K221177", "K190469", "K033695", "K112318", "K171637", "K031773", "K844550", "K111821", "K222734", "K202616", "K964196", "K810506", "K133734", "K102855", "K970764", "K130909", "K883173", "K934170", "K892426", "K242586", "K875264", "K200388", "K140405", "K143186", "K152278", "K862058", "K210618", "K953655" ], "registration_number": [ "9610617", "3010612620", "3010707607", "3008058134", "3005099803", "2029275", "3009217531", "1417592", "3007389669", "9610877", "2124215", "1423662", "1047843", "3011050570", "2518897", "3044707938", "3005245797", "3006950086", "3013460719", "3010202439", "3016678045", "3000974800", "3008720584", "3004167615", "3002807314", "3010383847", "3006696607", "3020712480", "3010230734", "3003207991", "3011219572", "3013348547", "9611680", "1000121056", "3004519921", "3006891611", "3010149039", "3004111573", "9616684", "3015309643", "3014342096", "3003790304", "1649518", "3009106214", "3014749926", "3010288205", "9610614", "1220477", "1722746", "1320894", "2020550", "3003637092", "3009538961", "3004762958", "1528319", "3002808148", "1721504", "3042872931", "1721676", "3017907746", "3009420598", "9614434", "9611590", "3004530184", "3015173212", "3021023752", "1000393132", "1650907", "2183446", "3021349683", "1018233", "3033589330", "3003782610", "1643817", "3012536737", "1037905", "3005580113", "2246552", "3006082230", "1651395", "3015225571", "3012042439", "3012322232", "2244478", "2183744", "3016096097", "9611174", "3032507796", "1220592", "3010273872", "2243757", "3011193403", "1216677", "8010047", "1221826", "3005726841", "2528981", "9610595" ], "fei_number": [ "3002807795", "3010612620", "3010707607", "3008058134", "3008185830", "3005099803", "3009217531", "1417592", "3007389669", "2124215", "1047843", "3002807969", "3011050570", "3044707938", "3005245797", "3006950086", "3013460719", "3016678045", "3000974800", "3008720584", "3005846326", "3004167615", "3002807314", "3010383847", "1000080301", "3006696607", "3020712480", "3010230734", "3003207991", "3003012447", "3011219572", "3013348547", "1000121056", "3001236277", "3002806920", "3006891611", "3010149039", "1000306431", "3004111573", "1000136269", "3015309643", "3014342096", "3003790304", "3009106214", "3014749926", "3002964398", "3002808273", "3010288205", "1220477", "3002681132", "1000162602", "2020550", "3003637092", "3002808268", "3009538961", "3004762958", "3007475226", "3002808148", "1721504", "3042872931", "3002913962", "1721676", "1000306216", "3017907746", "3009420598", "3000215273", "3004530184", "3015173212", "3021023752", "1000393132", "1000237915", "2183446", "3021349683", "1018233", "3033589330", "3003782610", "1643817", "3012536737", "1037905", "3005580113", "2246552", "3006082230", "1000122656", "3015225571", "3012042439", "3012322232", "2183744", "3016096097", "3032507796", "1220592", "3010273872", "2243757", "3011193403", "1216677", "1221826", "3005726841", "2528981", "3001451571" ], "device_name": "Endoscopic Irrigation/Suction System", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }