{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "115299", "product_res_number": "Z-0768-2013", "event_date_initiated": "2013-01-14", "event_date_posted": "2013-02-02", "recall_status": "Terminated", "event_date_terminated": "2013-07-17", "res_event_number": "64057", "product_code": "CAW", "k_numbers": [ "K020324" ], "product_description": "Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400.\nAlso branded as Reliability Plus byDrive. \nThe Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.", "code_info": "part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562.    Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258x, 08259x, 08260x, 08649x, 08650x, 08681x, 08807x, 08808x, 08811x, 09304x, 09387x, 09388x, 09390x, 09859x, 09860x, 10089x, 10402x, 10613x, 10614x, 10616x, 05407x, 06072x, 06078x, 06080x, 06081x, 06209x, 06217x, 06226x, 06277x, 06278x, 06279x, 06299x, 06329x, 06331x, 06396x, 06432x, 06433x, 06434x, 06436x, 06442x, 06443x, 06444x, 06445x, 06446x, 06474x, 06475x, 06476x, 06481x, 06512x, 06515x, 06517x, 06518x, 06522x, 06525x, 06810x, 06872x, 06874x, 06877x, 07030x, 07112x, 07113x, 07114x, 07116x, 07154x, 07169x, 07170x, 07171x, 07173x, 07194x, 05589x, and 07749x.", "firm_fei_number": "3008841036", "recalling_firm": "Oxus America, Inc.", "address_1": "1685 Northfield Dr", "city": "Rochester Hills", "state": "MI", "postal_code": "48309-3825", "reason_for_recall": "Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.", "root_cause_description": "Nonconforming Material/Component", "action": "Oxus, Inc. sent an \"URGENT: MEDICAL DEVICE RECALL\" letter dated January 11, 2013 to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 1-888-475-1568 for information related to this recall.", "product_quantity": "1724 total units", "distribution_pattern": "Worldwide Distribution-USA including the states of New York, Michigan, Colorado, Texas, Iowa, Florida, Georgia, Ohio, Wisconsin, Oregon, Alabama, Illinois, Utah, Oklahoma, West Virginia and California and the countries of Canada, European Union, South Africa, Korea and Brazil.", "openfda": { "k_number": [ "K081468", "K924565", "K041664", "K843243", "K830174", "K083559", "K952037", "K904002", "K091650", "K014301", "K061414", "K191875", "K120785", "K102750", "K843715", "K792149", "K952268", "K053229", "K032818", "K260171", "K162433", "K243833", "K812513", "K851438", "K914488", "K913327", "K954271", "K833495", "K131990", "K071608", "K903411", "K770157", "K250805", "K955549", "K090007", "K851437", "K043615", "K032509", "K200496", "K150930", "K993088", "K021685", "K822301", "K941145", "K073242", "K942357", "K252965", "K924146", "K864045", "K880262", 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"K842114", "K071928", "K021082", "K081267", "K852144", "K982243", "K884581", "K111885", "K003939", "K953949", "K864005", "K083163", "K080391", "K250625", "K043006", "K100920", "K851435", "K822889", "K760704", "K011844", "K080082", "K242736", "K971889", "K801104", "K872470", "K030920", "K102245", "K172234", "K843691", "K895141", "K842753", "K903608", "K844312", "K854374", "K971964", "K822871", "K761213", "K912794", "K003472", "K790520", "K062153", "K954506", "K123738", "K042944", "K831819", "K933081", "K813436", "K081206", "K904087", "K983777", "K896457", "K854509", "K942082", "K880044", "K972614", "K823582", "K883837", "K813018", "K844223", "K014078", "K120566", "K991569", "K981078", "K870064", "K013223", "K222086", "K134023", "K802426", "K813320", "K121260", "K131968", "K203210", "K081508", "K924152", "K902890", "K252399", "K960309", "K850253", "K981047", "K873526", "K843811", "K780020", "K780862", "K883591", "K071397", "K812693", "K252407", "K222920", "K823524", "K251764", "K924100", "K040892", "K984081", "K033405", "K852209", "K830046", "K830324", "K861435", "K202389", "K210371", "K050430", "K844852", "K821393", "K771761", "K251130", "K833938", "K020362", "K053240", "K242718", "K022684", "K881802", "K841102", "K810272", "K252616", "K223740", "K223379", "K030233", "K083751", "K860060", "K250671", "K813058", "K833500", "K855208", "K971947", "K020386", "K780366", "K012037", "K872534", "K935370", "K071461", "K951882", "K211056", "K821520", "K103563", "K801523", "K131016", "K200890", "K923650", "K884018", "K931355", "K213210", "K924818", "K132205", "K121531", "K132489", "K013931", "K190304" ], "registration_number": [ "3007344957", "3011191255", "1319044", "3013095415", "3042507287", "2515872", "3023245116", "2523148", "3015142815", "3011767915", "3006991053", "3009096682", "3003803075", "3033526676", "3008910673", "3014661487", "1924066", "3002807637", "3017684630", "3018783526", "3004972304", "3027241818", "3007573469", "3008841036", "3011895992", "3016809216", "3008220943", "3043648593", "3009128734", "2028807", "3037045878", "3007220521", "3043460907", "1220477", "3006534178", "3009683397", "3017608802", "3009550619", "3003637574", "3017520736", "3000126629", "3006240053", "3019385742", "2085602", "3004964590", "3015772781", "3014777423", "3014810929", "3008507279", "3005803793", "3005569927", "3032013079", "3017825461", "3011249646", "3025889185", "1000604079", "3045816954", "3011205710", "3005587132", "2518422", "3033814505", "3027605507", "3010287621", "2183615", "3010317211", "3016859940", "2032532", "3004112621", "3020476987", "1419185", "3007740533", "3001400310", "3023272766", "3004672275", "1039215", "3033859527", "3010440667", "3013000203", "9611451", "3005873568", "3029227324", "3003207908", "9710644", "3007307467", "3012316249", "3011120183" ], "fei_number": [ "3007344957", "3011191255", "3013095415", "3042507287", "2515872", "3023245116", "2523148", "3015142815", "3011767915", "3002806988", "3006991053", "3009096682", 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"3011120183" ], "device_name": "Generator, Oxygen, Portable", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5440", "device_class": "2" } } ] }