{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210312", "product_res_number": "Z-0147-2025", "event_date_initiated": "2024-07-18", "event_date_posted": "2024-10-23", "recall_status": "Open, Classified", "res_event_number": "95181", "product_code": "BYD", "product_description": "smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS", "code_info": "a) REF 100/582/000: UDI/DI 35019315022405, Lot Numbers: 4133230; UDI/DI 35019315010990, Lot Numbers: 4138707; UDI/DI 35019315011003, Lot Numbers: 4144947, 4147167; UDI/DI 35019315018156, Lot Numbers: 4135055, 4135056, 4135057, 4135059, 4135061, 4135063, 4147386, 4147387; UDI/DI 35019315022399, Lot Numbers: 4133228, 4133229; UDI/DI 35019315022429, Lot Numbers: 4141737, 4147168; UDI/DI 35019315022559, Lot Numbers: 4133814, 4147169; \n\nb) REF 100/582/000JP: UDI /DI 35019315018156, Lot Numbers: 4109285, 4109287, 4119729, 4131584, 4135055, 4135056, 4135057; \n\nc) REF 100/582/000JS: UDI/DI 35019315018156, Lot Numbers: 4135057", "firm_fei_number": "3012307300", "recalling_firm": "Smiths Medical ASD Inc.", "address_1": "6000 Nathan Ln N", "city": "Minneapolis", "state": "MN", "postal_code": "55442-1690", "additional_info_contact": "customer service\n800-258-5361", "reason_for_recall": "Uncertainty in the seal integrity of the sterile packaging.", "root_cause_description": "Packaging process control", "action": "Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. \nDistributors were directed to notify their customers by forwarding the notice. \nQuestions - contact smithsmedical.@sedgwick.com.", "product_quantity": "141,196 units", "distribution_pattern": "Worldwide distribution.", "openfda": { "k_number": [ "K881657", "K914336", "K881308", "K942794", "K935036", "K934441", "K903519", "K912336", "K903058", "K953540", "K840399", "K904193", "K941813", "K925622", "K952823", "K934190", "K903054", "K945657", "K912699", "K946209", "K952750", "K941535", "K881656", "K904338", "K873767", "K874597", "K862020", "K915786", "K952036", "K923910", "K953619", "K844040", "K912700", "K864095", "K950447", "K893875", "K945359", "K840398", "K944194", "K933597", "K954194", "K912333", "K900150", "K821365", "K872153", "K955008", "K903057", "K941987", "K941436", "K834292", "K953580", "K922946", "K951856", "K852601", "K952084", "K912335", "K912334", "K953491", "K953544", "K881644", "K902501", "K854012", "K873768", "K885313", "K953620", "K941585", "K952845", "K923865", "K953507", "K790681", "K952844", "K872371", "K943915" ], "registration_number": [ "", "2936999", "1000604079", "3004824601", "3003902312", "2529776", "3012453745", "3005012805", "3018094310", "1824226", "3006563173", "3010834934", "3044994756", "8040412", "3003836856", "3012262567", "3003898360", "3010957755", "3001313714", "3015495690", "3014208300", "3016674860", "3008278458", "3004030908", "3002807267", "3013576541", "3045058049", "3009747810", "3013507143", "8010485", "9616445", "3011503227", "3031233007", "3015142701", "3014054118", "3007648359", "3031369651", "3005998497", "3009887154", "3012521761", "2025816", "9616567", "2031897", "3010220595", "3004548776", "9617616", "3006061749", "3005587132", "3021039857", "3014747754", "9680661", "3010515776", "3010877292", "3013557562", "1058584", "3011987967", "1832562", "8010042", "3008693658", "3016634999", "2024841", "3016734145", "3021244152", "3002806603", "3011587055", "3010131137", "3020777588", "3013188547", "9710644", "3005519819", "3003862188", "3012002722", "3017937889", "3008311916", "3004905643", "3004365956", "3013242701", "3022568093", "1417592", "8043316", "3043619925", "1928237", "3011137372", "3023464160", "9617604", "3008770104", "3006534321", "3004530184", "8030673", "3030447506", "3004428458", "3010838917", "3004050971", "9710567", "3004116032", "3013530359", "8021995", "3011270181", "2028807", "1220479", "3006446479", "3010187802", "1314417", "9611500", "3010402691", "3012494290", "3006783791", "2183585", "3002907620", "3014579161", "3009171251", "3030733800", "3006984712", "3008567544", "3008806809", "3010321647", "1423662", "3005515211", "2025182", "3005855942", "8032044", "3037918935", "3010889742", "3016458361", "3043226252", "3016904853" ], "fei_number": [ "", "2936999", "1000604079", "3004824601", "3003902312", "3012453745", "3005012805", "3018094310", "1824226", "3002558692", "3006563173", "3010834934", "3044994756", "3003836856", "3012262567", "3003898360", "3010957755", "3015495690", "3014208300", "3000215273", "3016674860", "3008278458", "3004030908", "3002807267", "3013576541", "3045058049", "3009747810", "3013507143", "3002806269", "3011503227", "3031233007", "3015142701", "3014054118", "3007648359", "3031369651", "3002807293", "1000121196", "3005998497", "3009887154", "1000219637", "3012521761", "2025816", "3003256355", "3010220595", "3004548776", "3003949221", "3006061749", "3005749238", "3005587132", "3021039857", "3003361161", "3003319165", "3014747754", "3010515776", "3008581151", "3010877292", "3013557562", "3011987967", "1832562", "3008693658", "3016634999", "2024841", "3016734145", "3021244152", "3002806603", "3011587055", "3010131137", "3020777588", "3013188547", "3005519819", "3003862188", "3012002722", "3017937889", "3008311916", "3004905643", "3004365956", "3013242701", "3022568093", "1417592", "3043619925", "1928237", "3023464160", "3008770104", "3006363476", "3006534321", "3004530184", "3030447506", "3006759904", "3004428458", "3010838917", "3004050971", "3004116032", "3013530359", "3011270181", "1220479", "3006446479", "3002808696", "3010187802", "1314417", "3010402691", "3012494290", "3001104093", "3006783791", "2183585", "3002907620", "3014579161", "3003272754", "3030733800", "3006984712", "3008567544", "3009271244", "3008806809", "3002808128", "3010321647", "1000374126", "2025182", "3005515211", "3002963732", "3005855942", "3037918935", "3010889742", "3016458361", "3004213967", "3043226252", "3016904853", "3005747797" ], "device_name": "Condenser, Heat And Moisture (Artificial Nose)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5375", "device_class": "1" } } ] }