{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "220638", "product_res_number": "Z-2357-2026", "event_date_initiated": "2026-05-08", "event_date_posted": "2026-06-18", "recall_status": "Open, Classified", "res_event_number": "99036", "product_code": "BTM", "k_numbers": [ "K070247" ], "product_description": "Giraffe Stand-alone Infant Resuscitation System; Powered emergency ventilator (resuscitator)\r\nProduct identifiers: 2082663-001, 2082663-002, M1241424\r\n\r\nProduct impacted only if service blender M1091607-R was installed during the last Preventative Maintenance", "code_info": "UDI-DI of service blender component: 00813841020010\n\nAffected devices were installed with the following serial numbers of affected service blender 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"firm_fei_number": "3036470679", "recalling_firm": "Datex-Ohmeda Inc", "address_1": "3114 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE HealthCare Service\n800-437-1171", "reason_for_recall": "Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient.", "root_cause_description": "Process control", "action": "Firm began notifying customers on 5/8/2026 via letters titled \"URGENT MEDICAL DEVICE CORRECTION.\"\n\nCustomers were instructed to identify affected devices by following instructions provided in the letter. Devices with affected blenders should be removed from patient use, and the customer should contact a GE HealthCare Service Representative.", "product_quantity": "550 (367 US; 183 OUS)", "distribution_pattern": "Pending", "openfda": { "k_number": [ "K961868", "K932797", "K771175", "K874321", "K960468", "K822356", "K952512", "K902733", "K181583", "K944301", "K993194", "K972283", "K840935", "K961331", "K823710", "K802081", "K212905", "K910856", "K792118", "K922712", "K012271", "K023494", "K922004", "K922707", "K851171", "K221841", "K980066", "K911622", "K913474", "K892221", "K900260", "K895589", "K834250", "K922691", "K903631", "K094003", "K132172", "K981308", "K895351", "K243861", "K880394", "K921002", "K912203", "K913370", "K911298", "K904346", "K944347", "K831486", "K881086", "K881881", "K023793", "K973106", "K883434", "K073171", "K924215", "K053142", "K972139", "K002846", "K970959", "K915810", "K991953", "K992057", "K802231", "K940581", "K873286", "K970756", "K831198", "K901218", "K112852", "K791468", "K900577", "K902261", "K871147", "K991861", "K003927", "K964584", "K093081", "K031395", "K831885", "K955507", "K860693", "K933626", "K913714", "K854037", "K863026", "K842696", "K884068", "K913900", "K903570", "K905304", "K954866", "K780216", "K894365", "K102824", "K924671", "K152931", "K874567", "K961329", "K051177", "K850436", "K981307", "K852096", "K881087", "K802813", "K961332", "K840349", "K864308", "K032596", "K912620", "K874418", "K961330", "K881207", "K973419", "K881483", "K922810", "K072021", "K843223", "K021446", "K961882", "K882285", "K953546", "K832495", "K934699", "K914196", "K922819", "K920570", "K974141", "K844420", "K910040", "K914187", "K812273", "K941037", "K993278", "K842693", "K953617", "K822213", "K170663", "K882278", "K991955", "K884526", "K031434", "K823408", "K964719", "K833244", "K803066", "K042682", "K904899", "K053466", "K073410", "K771350", "K012842", "K860180", "K921982", "K970991", "K834400", "K070247", "K881686", "K042843", "K842487", "K961369", "K885243", "K082092", "K021442", "K954296", "K042556", "K934310", "K903443", "K953824", "K761025", "K875077", "K864125", "K761065", "K943617", "K053140", "K880450", "K030864", "K924217", "K905002", "K895169", "K014071", "K021390", "K895820", "K062080", "K873043", "K844729", "K900349", "K971243", "K911971", "K251631", "K923762", "K912625", "K924216", "K924610", "K102649", "K903438", "K812022", "K014115", "K021716", "K841496", "K930429", "K921553", "K210288", "K954150", "K952169", "K820059", "K021328", "K896886", "K982215", "K963848" ], "device_name": "Ventilator, Emergency, Manual (Resuscitator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5915", "device_class": "2", "registration_number": [ "2024500", "8021995", "3011137372", "9616445", "3008806809", "3013557562", "3003862188", "9616354", "2518436", "3005621729", "3015997711", "3006061749", "3011503227", "3014220748", "3010272829", "1024404", "3012104670", "1832562", "3005587132", "3011987967", "3015191173", "1417592", "3014507910", "3008264081", "3008729547", "8044169", "2518157", "3020460367", "9681848", "9610849", "3003924186", "3007734888", "3008311916", "3004111573", "2028807", "3038430561", "3031369651", "3005609751", "3027977504", "3003902679", "3004993040", "3008261717", "2025816", "9610483", "3034669683", "1526863", "9610691", "3006783791", "9610861", "1314417", "3022631687", "9617604", "9710567", "9710391", "3013484413", "8030673", "2020813", "3014579161", "3008818980", "3010402691", "3024753104", "9612374", "3006157842", "3036470679", "3017708978", "3004365956", "3003898360", "2022648", "8043316", "3038772438", "3030308442", "1924066", "3014656749", "2030745", "2648727" ], "fei_number": [ "2024500", "3000213164", "3000204983", "3008806809", "3013557562", "3003862188", "2518436", "3005747797", "3005621729", "3002807435", "3015997711", "3003256355", "3006061749", "3011503227", "3014220748", "3010272829", "1024404", "3012104670", "1832562", "3005587132", "3011987967", "3015191173", "1417592", "3014507910", "3008264081", "3008729547", "3003202124", "2518157", "3020460367", "3005749238", "3002806359", "3003924186", "3003319165", "3007734888", "3008311916", "3004111573", "3006363476", "1000283452", "3038430561", "3031369651", "3005609751", "3027977504", "3003902679", "3004993040", "3008261717", "3002806674", "2025816", "3034669683", "1526863", "3006783791", "1314417", "3002807836", "3022631687", "1000374126", "3002558692", "3002807391", "3013484413", "2020813", "3003418980", "3014579161", "3008818980", "3010402691", "3024753104", "3006157842", "3036470679", "3017708978", "3004213967", "3004365956", "3003898360", "2022648", "3038772438", "3030308442", "1924066", "3014656749", "2648727" ] } } ] }