{ "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": 11 } }, "results": [ { "cfres_id": "218139", "product_res_number": "Z-1326-2026", "event_date_initiated": "2025-12-24", "event_date_posted": "2026-02-09", "recall_status": "Open, Classified", "res_event_number": "98284", "product_code": "CAI", "product_description": "Medline medical convenience kits packaged as: ANESTHESIA ARTLINE PACK, Kit SKU DYNJ47387B", "code_info": "UDI/DI 10193489217070, Lot Number 25EBJ414", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n866-359-1704", "reason_for_recall": "Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.", "root_cause_description": "Packaging change control", "action": "Medline issued an URGENT MEDICAL DEVICE recall notice to its consignees on 12/24/2025 via USPS first class mail and email. The notice explained the issue, potential risk, and requested the consignee locate and quarantine the affected units and respond to the notice using the website link: https://recalls.medline.com; Recall Reference #: R-25-257-FGX1, and the specific code listed in the notice. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. \nDistributors and those who further distributed the affected its were directed to notify those to whom the kits were distributed or transferred, and include those quantities on the response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "120 kits", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K851529", "K800498", "K942123", "K942136", "K821087", "K953787", "K944429", "K901739", "K935044", "K811015", "K852316", "K942570", "K790115", "K932194", "K840850", "K932578", "K911736", "K925543", "K852311", "K911880", "K932486", "K862003", "K905148", "K912065", "K932192", "K904538", "K915452", "K842488", "K932588", "K932580", "K932488", "K932497", "K823714", "K932562", "K952009", "K830470", "K932583", "K812624", "K932576", "K801111", "K880683", "K942125", "K952018", "K852866", "K830475", "K945314", "K780044", "K932190", "K932288", "K932780", "K932558", "K932196", "K771134", "K770838", "K854573", "K942124", "K932577", "K770549", "K935168", "K840431", "K771017", "K932487", "K942135", "K852313", "K932579", "K942129", "K942133", "K942568", "K896365", "K851193", "K932707", "K944533", "K852312", "K905450", "K924889", "K911263", "K842492", "K813382", "K954480", "K870859", "K912504", "K771034", "K895357", "K781908", "K851530", "K925893", "K853343", "K852405", "K930713", "K932197", "K932587", "K952019", "K822379", "K822769", "K891479", "K932582", "K881141", "K932575", "K930252", "K841455", "K871386", "K932781", "K944295", "K945984", "K760819", "K913753", "K942122", "K932586", "K853344", "K821086", "K932485", "K945565", "K925231", "K932590", "K852632", "K940889", "K811700", "K932585", "K771307", "K833088", "K924627", "K853342", "K811413", "K922789", "K931487", "K942130", "K884072", "K942128", "K833871", "K851531", "K771518", "K893919", "K871669", "K801191", "K890499", "K952020", "K864588", "K910896", "K840056", "K932195", "K933641", "K833478", "K790214", "K760565", "K932489", "K942132", "K853065", "K896897", "K832453", "K792499", "K821311", "K840740", "K953788", "K820352", "K940890", "K861438", "K852315", "K942126", "K760149", "K900428", "K942131", "K833196", "K952017", "K932559", "K932193", "K952014", "K932710", "K852314", "K811858", "K925232", "K952016", "K932708", "K800499", "K844149", "K942134", "K934462", "K900594", "K841264", "K932589", "K932490", "K873359", "K770286", "K942127", "K926454" ], "registration_number": [ "", "2523320", "3003902679", "9611500", "9610849", "3010397428", "3010580321", "3016734145", "1824226", "1024404", "2022648", "3013298431", "3011587055", "3015191173", "3014579161", "8022265", "3010707607", "9616679", "3015058854", "3030446844", "2648727", "3007127332", "3013412170", "3014615028", "3006984712", "2112667", "3019793765", "3015134079", "3018366470", "9710567", "3005595283", "3036979319", "8044169", "2024500", "3017828726", "3015173212", "3015495690", "3001650535", "3021039857", "8010939", "8043316", "2028807", "9610105", "1282497", "3003898360", "3007289408", "3017202422", "2518436", "9617566", "3038293079", "3006897516", "9616088", "2936999", "3006606984", "9610617", "3016764932", "9616991", "3005012805", "9680661", "3017178358", "3002905553", "3005587132", "3016195240", "1061124", "2518157", "3008294339", "3018094310", "3015142721", "1722746", "3008867836", "1043214", "3020777588", "3017171849", "3006783791", "3022631687", "3013550220", "3007997596", "3001313714", "3018783526", "3010131137", "3009302812", "3011137372", "3016052406", "3014208300", "3003903031", "3023272766", "3045058049", "3009171251", "1218704", "3021010418", "8030673", "3021947238", "3016452400", "3029706818", "3034629649", "3000126629", "1924066", "3003449582", "8021995", "3010621964", "3013507143", "3031369651", "3010515776", "3015515504", "1836161", "1417592", "9611451", "3004111573", "3032012299", "1928237", "3014437893", "3005998497", "9616445", "3020460367", "3012187635", "3003862188", "3037918935", "8044099", "3010202439", "9710391", "3038562397", "1314417", "3004116032", "2518422", "3006546082", "3011185837", "3002807267", "3006666710", "2025816", "8010042", "3021244152", "2938401", "1420751", "3011780089", "3016634999", "9710644", "3012050423", "3010817335", "3010683054", "9617604", "3006534321", "3008157119", "1423537", "3009107690", "3015537026", "3010187802", "3010838917", "9681622", "3010889742", "3008693658", "3014916466", "3005767446", "3011986317", "3043619925", "8044004", "1319447", "3006897996", "1832562", "3006061749", "3013576541", "3005543241", "3010400865", "3004050971", "1423395", "3014342096", "3010439239", "3012834717", "3007092328", "3005273623", "3010834934", "3045816902", "9610861", "1000604079", "3004365956", "3006547005", "3008258694", "2085602", "3006210673", "3013530405", "3015168843", "2020550", "3013783488", "3018762668", "3038195661", "9616354", "2320762", "3015907115", "9681384", "3010402691", "3004122598", "3006446479", "3012494290", "9613910", "3016458361", "3044994756", "3011987967", "3013187142", "3006157842", "3010957755", "3008806809", "3013557562", "3044320625", "3005347827", "3001415205" ], "fei_number": [ "", "2523320", "3003902679", "3010397428", "3010580321", "3016734145", "1824226", "1024404", "3002808696", "2022648", "3013298431", "3011587055", "3015191173", "3014579161", "3002807293", "3010707607", "3015058854", "3030446844", "2648727", "3005749238", "3007127332", "3013412170", "3014615028", "3006984712", "3004458261", "3003418980", "2112667", "3003244771", "3019793765", "3015134079", "3018366470", "3005595283", "3002807836", "3003202124", "3036979319", "1000120301", "3005747797", "2024500", "3017828726", "3015173212", "3015495690", "3001650535", "3003205539", "3021039857", "3002902735", "3003952420", "3001227743", "1282497", "3001236905", "3003898360", "3007289408", "3017202422", "3002861325", "3038293079", "2518436", "3006897516", "2936999", "3006606984", "1000512168", "3016764932", "3001104093", "3005012805", "3017178358", "3002905553", "3005587132", "3016195240", "2518157", "3008294339", "3018094310", "3015142721", "1043214", "3008867836", "3003319165", "3020777588", "3017171849", "3006783791", "3022631687", "3013550220", "3007997596", "3018783526", "3010131137", "3009302812", "1000508235", "3003949221", "3016052406", "3003057578", "3003903031", "3006759904", "3014208300", "3023272766", "3045058049", "3021010418", "3021947238", "3016452400", "3029706818", "3034629649", "3000126629", "1924066", "3003449582", "3010621964", "3013507143", "3031369651", "3010515776", "3015515504", "1417592", "3032012299", "3004111573", "1928237", "1000306216", "3014437893", "3005998497", "3020460367", "3012187635", "3007475226", "3003862188", "3002750084", "3037918935", "3038562397", "1314417", "3004116032", "2518422", "3004213967", "3006546082", "3000717925", "3011185837", "3002807267", "3006666710", "2025816", "3021244152", "3002808440", "2938401", "1420751", "3011780089", "3016634999", "3002808128", "3012050423", "3002807626", "3010817335", "3010683054", "3008157119", "3006534321", "3009107690", "3004574120", "3015537026", "3010187802", "3010838917", "1000374126", "3002808268", "3010889742", "3002558692", "3008693658", "1000283452", "3014916466", "3005767446", "3011986317", "3043619925", "3003040625", "3006897996", "1832562", "3006061749", "3013576541", "3005543241", "3010400865", "3004050971", "3014342096", "3010439239", "3012834717", "3007092328", "3005273623", "3010834934", "3045816902", "3002807391", "1000604079", "3000210616", "3004365956", "3006547005", "3008258694", "3002806783", "3006210673", "3006363476", "3013530405", "3015168843", "2020550", "3013783488", "3018762668", "3038195661", "3015907115", "3010402691", "3004122598", "3006446479", "3012494290", "3016458361", "3044994756", "3011987967", "3013187142", "3006157842", "3010957755", "3008806809", "3013557562", "3044320625", "3005347827", "3001415205", "3003256355", "3002806988" ], "device_name": "Circuit, Breathing (W Connector, Adaptor, Y Piece)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5240", "device_class": "1" } } ] }