{ "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": "197181", "product_res_number": "Z-0725-2023", "event_date_initiated": "2022-12-05", "event_date_posted": "2022-12-19", "recall_status": "Open, Classified", "res_event_number": "91173", "product_code": "JET", "product_description": "Denticator PICK-A-DENT, periodontal aid - intradental pick, REF 621714", "code_info": "Lot 203257. \n\nRecall expanded on 12/19/2022 to include lot 207959", "firm_fei_number": "1941138", "recalling_firm": "Young Dental Manufacturing I, LLC", "address_1": "13705 Shoreline Ct E", "city": "Earth City", "state": "MO", "postal_code": "63045-1202", "additional_info_contact": "Mr. Jose Espino\n224-622-7191", "reason_for_recall": "mislabeled product", "root_cause_description": "Employee error", "action": "The firm issued an URGENT: MEDICAL DEVICE RECALL notice on 12/05/2022 to its consignees be certified mail. The notice explains the issue and requests either the return or discarding of the affected product. The response form indicates that their customers will be notified. \n\nOn 12/19/2022, firm expanded recall to include an additional affected lot. Customers were sent an updated URGENT: MEDICAL DEVICE RECALL notice on 12/19/2022, which included the same instructions.", "product_quantity": "600 packs", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of IA, NY, PA, TN, TX, and the country of Canada.", "openfda": { "k_number": [ "K885189", "K850775", "K890910", "K844238", "K860779", "K820979", "K881900", "K930178", "K821629", "K881046", "K963747", "K883225", "K911418", "K942633", "K832949" ], "device_name": "Pick, Massaging", "medical_specialty_description": "Dental", "regulation_number": "872.6650", "device_class": "1", "registration_number": [ "3002911411", "3003994666", "3042283835", "3005581016", "3011484520", "3008808087", "1051594", "2029275", "2029234", "3021245739", "2938386", "1718912", "3006400536", "3008770703", "3017268636", "3013972866", "3008346537", "2027062", "3016450032", "3005277354", "3015139713", "3001655856", "3010701675", "3015456958", "1941138", "1530449", "3013734586", "3011545201", "2133714", "2183301", "3009431661", "3004605493", "3007479587", "3000182940", "3014468707", "2920519", "3010864832", "2087561", "3010872518", "3013123677", "3009926836", "9710299", "3003965504", "3011089435", "3019741877", "3008478778", "3004789183", "3008808082", "3008076203", "3011545197", "3008925277", "3006536571", "1825660", "3004305946", "3004082121", "3009171220", "3005816808", "9615031", "9615399", "3011482376", "3019912897", "3016875543", "3012341715", "3016075921", "3011497834", "3024512680", "3015989868", "3014316197", "3009124884", "3012360263", "3010486573", "3017609565", "1836161", "9615008", "3012117640", "3010028831", "3007421127", "3011862887", "3038718579", "3018975080", "3003761382", "3004096300", "3017417635", "1719513", "3008770252", "3016245319", "8030607", "1419489", "3010119775", "3008344782", "3004069780", "3005558160", "3012133441", "3006113202", "3007663058", "3006639573", "3009560600", "9614443", "3006789197", "9616128", "1051614", "3003491259", "1421879", "3006639700", "3015977541", "3003487388", "3012134276", "3011554142", "3007327603", "3016427447", "3005831677", "3003799843", "2018957", "3033615362", "3007345409", "2086043", "3033918991", "1413787", "3003618527", "3009488700", "3011964664", "3010401517", "3012118920", "3015548849", "3018762668", "3025414363" ], "fei_number": [ "3002911411", "1000115048", "3003994666", "3042283835", "3005581016", "3011484520", "3008808087", "1051594", "3021245739", "2938386", "3002096276", "1718912", "3006400536", "3008770703", "3017268636", "3013972866", "3008346537", "2027062", "3016450032", "3005277354", "3015139713", "3001655856", "3010701675", "3015456958", "1941138", "3013734586", "3011545201", "2183301", "3009431661", "3004605493", "3007479587", "3000182940", "3014468707", "2920519", "3002750084", "3010872518", "3013123677", "3009926836", "1000220911", "1000306431", "3003965504", "3006509795", "3011089435", "3019741877", "3008478778", "3010138769", "3004789183", "3008808082", "3008076203", "3011545197", "3006536571", "1825660", "3004305946", "3004082121", "3009171220", "3003374116", "3000719926", "3005816808", "3011482376", "3019912897", "3016875543", "3012341715", "1000184564", "3016075921", "3011497834", "3004137526", "3024512680", "3015989868", "3014316197", "3009124884", "3012360263", "3010486573", "3017609565", "3000209941", "3012117640", "3010028831", "3007421127", "3011862887", "3038718579", "3018975080", "3003761382", "3004096300", "3017417635", "1719513", "3008770252", "3016245319", "3000719964", "3010862763", "1419489", "3010119775", "3008344782", "3004069780", "3005558160", "3012133441", "3006113202", "3007663058", "3006639573", "3009560600", "3006789197", "1051614", "3003491259", "3006639700", "3015977541", "3003487388", "3012134276", "3011554142", "3007327603", "3016427447", "3005831677", "3002574147", "3003799843", "2018957", "3033615362", "3007345409", "3033918991", "1413787", "3003618527", "3009488700", "3011964664", "3002993235", "3010401517", "3012118920", "3015548849", "3018762668", "3025414363" ] } } ] }