{ "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": "2026-10-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "213696", "product_res_number": "Z-1814-2025", "event_date_initiated": "2025-05-01", "event_date_posted": "2025-05-30", "recall_status": "Open, Classified", "res_event_number": "96801", "product_code": "BTM", "k_numbers": [ "K953546" ], "product_description": "Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F", "code_info": "UDI-DI: \nEA: 10884389164822\nCS: 40884389164823\n\nLots:\n526782\n526790\n526796\n526797\n526798\n526800\n526802\t\n526804\n526805\n526806\n526807\n526808\n526809\n526810\t\n526814\n526815\n526816\n526811\n526817\n526818", "firm_fei_number": "1314417", "recalling_firm": "SunMed Holdings, LLC", "address_1": "2710 Northridge Dr Nw Ste A 2710 Northridge Dr Nw", "address_2": "Ste A", "city": "Grand Rapids", "state": "MI", "postal_code": "49544-9112", "additional_info_contact": "Jessica Hoke\n616-259-8400", "reason_for_recall": "Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.", "root_cause_description": "Process control", "action": "Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed.\n\nIf you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.", "product_quantity": "11,358", "distribution_pattern": "US Nationwide distribution via Medline.", "openfda": { "k_number": [ "K094003", "K812022", "K842696", "K863026", "K831198", "K792118", "K882285", "K042682", "K961868", "K831486", "K934310", "K062080", "K031434", "K881686", "K181583", "K901218", "K874321", "K910856", "K941037", "K905304", "K961332", "K251631", "K834250", "K921982", "K860180", "K771175", "K903631", "K864308", "K944301", "K221841", "K881483", "K900577", "K991955", "K896886", "K904346", "K960468", "K924671", "K883434", "K924610", "K021446", "K840935", "K972139", "K903570", "K920570", "K895169", "K791468", "K955507", "K844420", "K961882", "K070247", "K961329", "K921002", "K970991", "K912203", "K152931", "K981308", "K803066", "K132172", "K072021", "K913370", "K922810", "K970959", "K842487", "K053466", "K914196", "K895589", "K834400", "K874567", "K913714", "K905002", "K802231", "K822213", "K873043", "K953824", "K964584", "K840349", "K832495", "K954150", "K930429", "K922707", "K895820", "K102824", "K944347", "K820059", "K880450", "K212905", "K961369", "K973419", "K243861", "K902733", "K771350", "K943617", "K852096", "K924215", "K982215", "K012271", "K851171", "K884068", "K892221", "K904899", "K912620", "K823408", "K910040", "K843223", "K073410", "K952512", "K952169", "K030864", "K831885", "K940581", "K780216", "K023494", "K993278", "K933626", "K973106", "K012842", "K210288", "K014115", "K970756", "K900349", "K991861", "K961331", "K102649", "K053142", "K972283", "K993194", "K842693", "K912625", "K860693", "K913474", "K991953", "K971243", "K922712", "K053140", "K921553", "K003927", "K874418", "K954866", "K961330", "K082092", "K923762", "K953617", "K914187", "K841496", "K850436", "K980066", "K093081", "K881087", "K002846", "K021390", "K051177", "K864125", "K900260", "K823710", "K981307", "K911971", "K964719", "K882278", "K875077", "K761065", "K963848", "K934699", "K911298", "K915810", "K112852", "K802081", "K854037", "K953546", "K023793", "K802813", "K822356", "K021442", "K911622", "K895351", "K894365", "K913900", "K042843", "K924217", "K833244", "K042556", "K881086", "K903438", "K881207", "K761025", "K924216", "K881881", "K885243", "K974141", "K812273", "K170663", "K954296", "K871147", "K922819", "K880394", "K902261", "K031395", "K032596", "K021328", "K073171", "K884526", "K873286", "K014071", "K992057", "K922004", "K021716", "K932797", "K844729", "K922691", "K903443" ], "registration_number": [ "3014656749", "8030673", "3014579161", "9710391", "2030745", "8021995", "3008264081", "3004111573", "3006783791", "3006157842", "3036470679", "3014507910", "3022631687", "3003902679", "9617604", "2648727", "3014220748", "3005621729", "2028807", "2022648", "3005587132", "3008806809", "3031369651", "3008261717", "8043316", "3003862188", "3030308442", "1526863", "3015997711", "2020813", "3011987967", "9610861", "3010402691", "3010272829", "3006061749", "9681848", "2518157", "1417592", "3008311916", "3024753104", "9612374", "3008729547", "2024500", "9710567", "3038430561", "3027977504", "9616445", "3038772438", "3017708978", "3013557562", "3004365956", "3003924186", "9610691", "9616354", "3005609751", "3012104670", "3020460367", "3011137372", "3007734888", "3034669683", "1924066", "3004993040", "8044169", "1832562", "9610483", "1024404", "3011503227", "2025816", "1314417", "3013484413", "3003898360", "9610849", "2518436", "3012311599", "3015191173" ], "fei_number": [ "3014656749", "3006363476", "3014579161", "3002806674", "3002807391", "3003319165", "3008264081", "3004111573", "3006783791", "3006157842", "1000374126", "3036470679", "3014507910", "3022631687", "3003902679", "1000283452", "2648727", "3014220748", "3005621729", "3003202124", "2022648", "3005587132", "3008806809", "3031369651", "3000204983", "3008261717", "3030308442", "3003862188", "1526863", "3015997711", "2020813", "3011987967", "3010402691", "3010272829", "3006061749", "3002806359", "2518157", "1417592", "3008311916", "3015191173", "3024753104", "3008729547", "2024500", "3038430561", "3027977504", "3002558692", "3038772438", "3017708978", "3013557562", "3005749238", "3004213967", "3004365956", "3003924186", "3003418980", "3005609751", "3003256355", "3012104670", "3020460367", "3000213164", "3034669683", "3007734888", "1924066", "3004993040", "1832562", "3002807836", "3002807435", "1024404", "3011503227", "2025816", "1314417", "3013484413", "3003898360", "2518436", "3012311599", "3005747797" ], "device_name": "Ventilator, Emergency, Manual (Resuscitator)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5915", "device_class": "2" } } ] }