{ "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": "190173", "product_res_number": "Z-0482-2022", "event_date_initiated": "2021-11-16", "event_date_created": "2022-01-11", "recall_status": "Open, Classified", "res_event_number": "88984", "product_code": "BTA", "k_numbers": [ "K933902" ], "product_description": "Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.", "code_info": "Shipped between March 2019 and February 2021.", "firm_fei_number": "1419185", "recalling_firm": "Ohio Medical Corporation", "address_1": "1111 Lakeside Dr", "city": "Gurnee", "state": "IL", "postal_code": "60031-2489", "additional_info_contact": "Customer Service\n800-448-0770", "reason_for_recall": "Increase in premature device failures", "root_cause_description": "Employee error", "action": "The firm notified their consignees by letter beginning 11/16/2021 via USPS. The letter identified the defect and requested the return of the affected devices for testing unless it is not feasible to do so. Consignees were provided an alternative option for on site testing if the device could not be returned.", "product_quantity": "649 portable suction pumps and replacement pumps", "distribution_pattern": "US Nationwide, including PR. There was government and foreign distribution. There was no military distribution.", "openfda": { "k_number": [ "K840110", "K813095", "K930549", "K852646", "K843693", "K970186", "K242028", "K180863", "K090379", "K873462", "K981703", "K843750", "K141255", "K033179", "K253107", "K952806", "K040239", "K233901", "K993668", "K952632", "K850946", "K960492", "K980301", "K932051", "K926566", "K952103", "K820739", "K844200", "K941578", "K051758", "K103042", "K973268", "K934976", "K260134", "K851560", "K221042", "K231063", "K951423", "K984363", "K250697", "K853917", "K920628", "K081185", "K253629", "K141553", "K813312", "K873940", "K841903", "K862569", "K953132", "K090445", "K921107", "K042943", "K181667", "K954287", "K062801", "K232831", "K041154", "K921611", "K944116", "K940934", "K853909", "K992026", "K821321", "K933757", "K954264", "K842204", "K093241", "K971749", "K862751", "K243138", "K933902", "K944818", "K220126", "K812020", "K251101", "K891129", "K241799", "K932494", "K950495", "K052650", "K951326", "K041405", "K043544", "K080212", "K982371", "K180606", "K874157", "K130123", "K130131", "K981602", "K941961", "K862875", "K241202", "K153459", "K153663", "K980454", "K201203", "K241852", "K013116", "K832100", "K932031", "K841399", "K941096", "K260892", "K173389", "K971107", "K251450", "K013585", "K870094", "K964997", "K140179", "K011601", "K945929", "K222856", "K244033", "K944399", "K203135", "K854844", "K122619", "K983552", "K951729", "K061133", "K831007", "K260147", "K021368", "K130210", "K883582", "K840803", "K922176", "K843644", "K931348", "K963775", "K062610", "K170533", "K061205", "K080745", "K860030", "K071607", "K910271", "K954286", "K041199", "K223373", "K221676", "K980392", "K810490", "K092903", "K260473", "K832274", "K052626", "K820338", "K222547", "K831085", "K161002", "K871570", "K833785", "K791349", "K965059", "K942033" ], "registration_number": [ "9610617", "3013758550", "3004050971", "1060680", "3010707607", "1220908", "3013298431", "1417592", "3004378299", "9610612", "2523148", "3015615738", "3011050570", "3038259592", "3005813597", "2022724", "3010202439", "3014827316", "1450908", "3027605322", "3007305485", "3003781173", "3003509351", "3006174295", "3015924074", "3019924", "2032112", "2134752", "1219343", "3010659128", "9614936", "3005803793", "3014342096", "3006142527", "3004443928", "3006789357", "3016661562", "3012684779", "9613895", "9617787", "8010573", "2020550", "3011716786", "3023876581", "3002807523", "3021595514", "2132111", "1000122786", "9610861", "3009538961", "1419937", "3012797688", "3042156936", "2024022", "3013095415", "3020476987", "3013556777", "3011816507", "3005527904", "9680961", "1043214", "1649660", "1721676", "3006617533", "3029871637", "3004727197", "3004464325", "3010034780", "3004145393", "9614434", "1000604079", "3014718111", "3008837339", "3009039068", "3004993040", "3013857114", "3010079067", "3017493034", "9680741", "3016904853", "3007360714", "3017435705", "9617543", "3025428426", "3031563234", "3012322232", "3017520736", "3021376102", "3014273557", "9611174", "3038634684", "3007143859", "3005168196", "3016591327", "3015177409", "1419185", "1924066", "3005146144", "3026986849" ], "fei_number": [ "3013758550", "3004050971", "3010707607", "1220908", "3013298431", "3003272793", "1000208624", "1417592", "3004378299", "2523148", "3015615738", "3011050570", "3038259592", "3005813597", "3002806315", "2022724", "3014827316", "1450908", "3027605322", "3007305485", "3003781173", "3003509351", "3006174295", "3015924074", "3003076831", "3019924", "3005479955", "1219343", "3010659128", "3005803793", "3014342096", "3006142527", "1000121355", "3002808273", "3002808224", "3005601686", "3004443928", "3006789357", "3016661562", "3012684779", "1000162602", "2020550", "3011716786", "3023876581", "3002807523", "3021595514", "3002808268", "1000122786", "3009538961", "1419937", "3012797688", "3042156936", "2024022", "3013095415", "3020476987", "3013556777", "3007475226", "3011816507", "3005527904", "1043214", "1721676", "3006617533", "3004145393", "3004727197", "3029871637", "3010034780", "3004464325", "3001451796", "3003169291", "3002345941", "1000604079", "3003007822", "3008837339", "3009039068", "3002807836", "3004993040", "3013857114", "3010079067", "3017493034", "1000140026", "3016904853", "3007360714", "3017435705", "3025428426", "3031563234", "3012322232", "3017520736", "3021376102", "3014273557", "3038634684", "3007143859", "3005168196", "3016591327", "3003327833", "3015177409", "1419185", "1924066", "3005146144", "3026986849" ], "device_name": "Pump, Portable, Aspiration (Manual Or Powered)", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4780", "device_class": "2" } } ] }