{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210660", "product_res_number": "Z-0478-2025", "event_date_initiated": "2024-10-04", "event_date_posted": "2024-11-15", "recall_status": "Completed", "res_event_number": "95576", "product_code": "CAW", "k_numbers": [ "K020324" ], "product_description": "CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.", "code_info": "UDI-DI: M766AS20010; Serial numbers: CBB5224380296, CBB5224380292, CBB5224380285, CBB5224380284, CBB5224380283, CBB5224380281, CBB5224380279, CBB5224380278, CBB5224380277, CBB5224380276, CBB5224380273, CBB5224380271, CBB5224380270, CBB5224380268, CBB5224380267, CBB5224380266, CBB5224380264, CBB5224380263, CBB5224380262, CBB5224380257, CBB5224380256, CBB5224380250, CBB5224380248, CBB5224380246, CBB5224380245, CBB5224380244, CBB5224380063, CBB5224380062, CBB5224380061, CBB5224380059, CBB5224380058, CBB5224380057, CBB5224380056, CBB5224380053, CBB5224380052, CBB5224380051, CBB5224380050, CBB5224380049, CBB5224380048, CBB5224380047, CBB5224380046, CBB5224380044, CBB5224380043, CBB5224380042, CBB5224380041, CBB5224380040, CBB5224380039, CBB5224380038, CBB5224380037, CBB5224380036, CBB5224380035, CBB5224380034, CBB5224380033, CBB5224380032, CBB5224380031, CBB5224380030, CBB5224380029, CBB5224380028, CBB5224380027, CBB5224380026, CBB5224380025, CBB5224380023, CBB5224380022, CBB5224380021, CBB5224380020, CBB5224380019, CBB5224380018, CBB5224380017, CBB5224380016, CBB5224380015, CBB5224380014, CBB5224380013, CBB5224380012, CBB5224380006, CBB5224380005, CBB5224380004, CBB5224380002, CBB5224370690, CBB5224370689, CBB5224370688, CBB5224370687, CBB5224370686, CBB5224370685, CBB5224370684, CBB5224370683, CBB5224370682, CBB5224370681, CBB5224370677, CBB5224370676, CBB5224370675, CBB5224370674, CBB5224370673, CBB5224370672, CBB5224370671, CBB5224370670, CBB5224370669, CBB5224370667, CBB5224370666, CBB5224370665, CBB5224370664, CBB5224370662, CBB5224370661, CBB5224370660, CBB5224370659, CBB5224370658, CBB5224370657, CBB5224370656, CBB5224370655, CBB5224370654, CBB5224370652, CBB5224370649, CBB5224370648, CBB5224370647, CBB5224370646, CBB5224370640, CBB5224370639, CBB5224370638, CBB5224370637, CBB5224370636, CBB5224370635, CBB5224370634, CBB5224370633, CBB5224370615, CBB5224370614, CBB5224370613, CBB5224370612, CBB5224370611, CBB5224370610, CBB5224370609, CBB5224370608, CBB5224370607, CBB5224370606, CBB5224370605, CBB5224370604, CBB5224370602, CBB5224370601, CBB5224370600, CBB5224370597, CBB5224370596, CBB5224370595, CBB5224370594, CBB5224370593, CBB5224370592, CBB5224370591, CBB5224370590, CBB5224370589, CBB5224370588, CBB5224370587, CBB5224370586, CBB5224370585, CBB5224370584, CBB5224370583, CBB5224370582, CBB5224370581, CBB5224370580, CBB5224370579, CBB5224370578, CBB5224370577, CBB5224370576, CBB5224370575, CBB5224370574, CBB5224370573, CBB5224370572, CBB5224370571, CBB5224370570, CBB5224370569, CBB5224370568, CBB5224370567, CBB5224370566, CBB5224370565, CBB5224370564, CBB5224370563, CBB5224370562, CBB5224370561, CBB5224370560, CBB5224370559, CBB5224370558, CBB5224370557, CBB5224370556, CBB5224370555, CBB5224370554, CBB5224370553, CBB5224370552, CBB5224370551, CBB5224370550, CBB5224370548, CBB5224370547, CBB5224370546, CBB5224370545, CBB5224370544, CBB5224370542, CBB5224370541, CBB5224370540, CBB5224370539, CBB5224370538, CBB5224370537, CBB5224370536, CBB5224370535, CBB5224370534, CBB5224370533, CBB5224370532, CBB5224370531, CBB5224370530, CBB5224370529, CBB5224370528, CBB5224370527, CBB5224370525, CBB5224370524, CBB5224370523, CBB5224370522, CBB5224370521, CBB5224370520, CBB5224370519, CBB5224370518, CBB5224370517, CBB5224370516, CBB5224370515, CBB5224370514, CBB5224370513, CBB5224370512, CBB5224370511, CBB5224370510, CBB5224370509, CBB5224370508, CBB5224370507, CBB5224370506, CBB5224370504, CBB5224370503, CBB5224370502, CBB5224370501, CBB5224370500, CBB5224370499, CBB5224370498, CBB5224370496, CBB5224370494, CBB5224370492, CBB5224370491, CBB5224370490, CBB5224370488, CBB5224370487, CBB5224370486, CBB5224370485, CBB5224370484, CBB5224370483, CBB5224370482, CBB5224370481, CBB5224370480, CBB5224370479, CBB5224370478, CBB5224370476, CBB5224370475, CBB5224370474, CBB5224370473, CBB5224370472, CBB5224370471, CBB5224370468, CBB5224370467, CBB5224370466, CBB5224370463, CBB5224370462, CBB5224370461, CBB5224370460, CBB5224370456, CBB5224370455, CBB5224370454, CBB5224370453, CBB5224370452, CBB5224370449, CBB5224370447, CBB5224370446, CBB5224370444, CBB5224370443, CBB5224370442, CBB5224370441, CBB5224370440, CBB5224370439, CBB5224370438, CBB5224370437, CBB5224370436, CBB5224370435, CBB5224370434, CBB5224370433, CBB5224370432, CBB5224370430, CBB5224370427, CBB5224370426, CBB5224370425, CBB5224370424, CBB5224370423, CBB5224370422, CBB5224370419, CBB5224370418, CBB5224370417, CBB5224370416, CBB5224370415, CBB5224370413, CBB5224370412, CBB5224370410, CBB5224370408, CBB5224370406, CBB5224370405, CBB5224370402, CBB5224370401, CBB5224370400, CBB5224370399, CBB5224370398, CBB5224370397, CBB5224370396, CBB5224370395, CBB5224370393, CBB5224370392, CBB5224370391, CBB5224370390, CBB5224370389, CBB5224370388, CBB5224370387, CBB5224370386, CBB5224370385, CBB5224370384, CBB5224370383, CBB5224370382, CBB5224370381, CBB5224370380, CBB5224370379, CBB5224370378, CBB5224370377, CBB5224370376, CBB5224370375, CBB5224370374, CBB5224370373, CBB5224370372, CBB5224370371, CBB5224370370, CBB5224370369, CBB5224370367, CBB5224370365, CBB5224370364, CBB5224370363, CBB5224370361, CBB5224370360, CBB5224370359, CBB5224370358, CBB5224370357, CBB5224370356, CBB5224370355, CBB5224370354, CBB5224370353, CBB5224370352, CBB5224370351, CBB5224370350, CBB5224370349, CBB5224370348, CBB5224370347, CBB5224370346, CBB5224370345, CBB5224370344, CBB5224370343, CBB5224370341, CBB5224370340, CBB5224370339, CBB5224370338, CBB5224370337, CBB5224370336, CBB5224370334, CBB5224370332, CBB5224370331, CBB5224370330, CBB5224370329, CBB5224370328, CBB5224370327, CBB5224370326, CBB5224370325, CBB5224370324, CBB5224370322, CBB5224370320, CBB5224370319, CBB5224370318, CBB5224370317, CBB5224370316, CBB5224370315, CBB5224370313, CBB5224370312, CBB5224370311, CBB5224370310, CBB5224370308, CBB5224370307, CBB5224370306, CBB5224370305, CBB5224370303, CBB5224370301, CBB5224370300, CBB5224370299, CBB5224370298, CBB5224370296, CBB5224370294, CBB5224370293, CBB5224370291, CBB5224370290, CBB5224370289, CBB5224370288, CBB5224370287, CBB5224370286, CBB5224370284, CBB5224370283, CBB5224370282, CBB5224370281, CBB5224370280, CBB5224370279, CBB5224370278, CBB5224370277, CBB5224370276, CBB5224370275, CBB5224370274, CBB5224370273, CBB5224370272, CBB5224370271, CBB5224370270, CBB5224370269, CBB5224370267, CBB5224370266, CBB5224370263, CBB5224370262, CBB5224370261, CBB5224370260, CBB5224370259, CBB5224370258, CBB5224370257, CBB5224370255, CBB5224370254, CBB5224370253, CBB5224370252, CBB5224370251, CBB5224370250, CBB5224370249, CBB5224370247, CBB5224370246, CBB5224370245, CBB5224370244, CBB5224370243, CBB5224370241, CBB5224370240, CBB5224370239, CBB5224370238, CBB5224370237, CBB5224370236, CBB5224370235, CBB5224370233, CBB5224370232, CBB5224370231, CBB5224370229, CBB5224370228, CBB5224370226, CBB5224370225, CBB5224370224, CBB5224370223, CBB5224370222, CBB5224370221, CBB5224370220, CBB5224370219, CBB5224370218, CBB5224370217, CBB5224370216, CBB5224370215, CBB5224370214, CBB5224370213, CBB5224370212, CBB5224370211, CBB5224370210, CBB5224370209, CBB5224370208, CBB5224370207, CBB5224370206, CBB5224370205, CBB5224370204, CBB5224370203, CBB5224370202, CBB5224370201, CBB5224370200, CBB5224370198, CBB5224370197, CBB5224370196, CBB5224370195, CBB5224370193, CBB5224370192, CBB5224370190, CBB5224370189, CBB5224370188, CBB5224370187, CBB5224370186, CBB5224370184, CBB5224370182, CBB5224370181, CBB5224370180, CBB5224370179, CBB5224370178, CBB5224370177, CBB5224370176, CBB5224370175, CBB5224370174, CBB5224370173, CBB5224370172, CBB5224370171, CBB5224370170, CBB5224370169, CBB5224370167, CBB5224370166, CBB5224370164, CBB5224370163, CBB5224370161, CBB5224370160, CBB5224370159, CBB5224370158, CBB5224370157, CBB5224370156, CBB5224370155, CBB5224370154, CBB5224370153, CBB5224370152, CBB5224370151, CBB5224370150, CBB5224370149, CBB5224370148, CBB5224370147, CBB5224370146, CBB5224370145, CBB5224370144, CBB5224370143, CBB5224370142, CBB5224370141, CBB5224370140, CBB5224370139, CBB5224370138, CBB5224370137, CBB5224370136, CBB5224370135, CBB5224370134, CBB5224370133, CBB5224370132, CBB5224370131, CBB5224370130, CBB5224370129, CBB5224370128, CBB5224370127, CBB5224370126, CBB5224370125, CBB5224370124, CBB5224370123, CBB5224370122, CBB5224370121, CBB5224370120, CBB5224370119, CBB5224370118, CBB5224370117, CBB5224370116, CBB5224370115, CBB5224370114, CBB5224370113, CBB5224370111, CBB5224370109, CBB5224370108, CBB5224370107, CBB5224370106, CBB5224370105, CBB5224370103, CBB5224370102, CBB5224370101, CBB5224370100, CBB5224370099, CBB5224370096, CBB5224370094, CBB5224370093, CBB5224370090, CBB5224370089, CBB5224370088, CBB5224370087, CBB5224370086, CBB5224370085, CBB5224370084, CBB5224370083, CBB5224370082, CBB5224370081, CBB5224370080, CBB5224370079, CBB5224370077, CBB5224370076, CBB5224370075, CBB5224370074, CBB5224370073, CBB5224370072, CBB5224370071, CBB5224370070, CBB5224370069, CBB5224370068, CBB5224370067, CBB5224370066, CBB5224370065, CBB5224370064, CBB5224370063, CBB5224370062, CBB5224370061, CBB5224370060, CBB5224370059, CBB5224370018, CBB5224370017, CBB5224370014, CBB5224370013, CBB5224370012, CBB5224370008, CBB5224370007, CBB5224370005, CBB5224370004, CBB5224360439, CBB5224360436, CBB5224360435, CBB5224360434, CBB5224360433, CBB5224360431, CBB5224360428, CBB5224360427, CBB5224360426, CBB5224360425, CBB5224360424, CBB5224360423, CBB5224360422, CBB5224360421, CBB5224360420, CBB5224360419, CBB5224360418, CBB5224360412, CBB5224360410, CBB5224360409, CBB5224360402, CBB5224360401, CBB5224360400, CBB5224360396, CBB5224360394, CBB5224360393, CBB5224360392, CBB5224360389, CBB5224360388, CBB5224360386, CBB5224360382, CBB5224360381, CBB5224360380, CBB5224360379, CBB5224360377, CBB5224360375, CBB5224360372, CBB5224360368, CBB5224360367, CBB5224360363, CBB5224360362, CBB5224360354, CBB5224360341, CBB5224360329, CBB5224360325, CBB5224360295, CBB5224360285, CBB5224360268, CBB5224360250, CBB5224360247, CBB5224360242, CBB5224360235, CBB5224360232, CBB5224360229, CBB5224360225, CBB5224360220, CBB5224360214, CBB5224360213, CBB5224360212, CBB5224360211, CBB5224360209, CBB5224360208, CBB5224360207, CBB5224360204, CBB5224360203, CBB5224360201, CBB5224360200, CBB5224360199, CBB5224360195, CBB5224360190, CBB5224360186, CBB5224360183, CBB5224360181, CBB5224360175, CBB5224360170, CBB5224360169, CBB5224360166, CBB5224360155, CBB5224360154, CBB5224360152, CBB5224360149, CBB5224360146, CBB5224360144, CBB5224360130, CBB5224360104, CBB5224360102, CBB5224360101, CBB5224360097, CBB5224360096, CBB5224360095, CBB5224360090, CBB5224360087, CBB5224360086, CBB5224360074, CBB5224360064, CBB5224360060, CBB5224360059, CBB5224360056, CBB5224360055, CBB5224360054, CBB5224360043, CBB5224360039, CBB5224360034, CBB5224360032, CBB5224360029, CBB5224360025, CBB5224360005, CBB5224360004, CBB5224350827, CBB5224350822, CBB5224350821, CBB5224350818, CBB5224350815, CBB5224350813, CBB5224350802, CBB5224350801, CBB5224350797, CBB5224350795, CBB5224350793, CBB5224350791, CBB5224350787, CBB5224350786, CBB5224350785, CBB5224350782, CBB5224350359, CBB5224350297, CBB5224300234, and CBB5221310366.", "firm_fei_number": "3004972304", "recalling_firm": "Caire, Inc.", "address_1": "2200 Airport Industrial Dr Ste 500 2200 Airport Industrial Dr", "address_2": "Ste 500", "city": "Ball Ground", "state": "GA", "postal_code": "30107-4686", "additional_info_contact": "Sheril Ray\n770-7217719", "reason_for_recall": "Potential failure of affected units to recharge the battery of the oxygen concentrators.", "root_cause_description": "Nonconforming Material/Component", "action": "The recalling firm issued letters via email on and dated 10/4/2024 to their \"sold-to\" DME (durable medical equipment) distributors. The letter explained the reason for recall, identified the affected serial numbers and when they were shipped to the DME distributor, and requested the devices be returned to the recalling firm immediately. They are informed the devices will be replaced with new or repaired units. The DME distributor is to contact the CAIRE Customer Service via phone or email to arrange for return of the devices. A Response Form: Acknowledgement of Receipt was enclosed to indicate they have read and understand the recall instructions.", "product_quantity": "739 concentrators", "distribution_pattern": "Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.", "openfda": { "k_number": [ "K884018", "K971889", "K040738", "K081206", "K141967", "K791437", "K955549", "K213210", "K895141", "K100957", "K093308", "K012037", "K935370", "K780862", "K080082", "K903608", "K844312", "K843243", "K851439", "K802426", "K072688", "K851434", "K073242", "K811155", "K252407", "K823524", "K011844", "K191159", "K851435", "K884563", "K924565", "K844328", "K843691", "K192693", "K132489", "K851438", "K813320", "K021685", "K020330", "K791043", "K123738", "K942357", "K822871", "K913327", "K061261", "K983627", "K080391", "K790520", "K060922", "K954506", "K942082", "K083163", "K873526", "K822301", "K861011", "K041664", "K100920", "K003939", "K971964", "K030233", "K830174", "K904639", "K150930", "K971129", "K091716", "K013931", "K983777", "K830046", "K252616", "K850253", "K083559", "K240561", "K803232", "K801104", "K854374", "K864045", "K191875", "K771761", "K924152", "K253549", "K013223", "K251764", "K981078", "K891488", "K014078", "K172648", "K873071", "K971947", "K132205", "K903411", "K081267", "K880262", "K904087", "K243833", "K991569", "K103563", "K120566", "K250671", "K904271", "K251534", "K860060", "K821520", "K904002", "K954271", "K053240", "K880261", "K021082", "K861435", "K842753", "K821393", "K812282", "K895177", "K200890", "K082566", "K810411", "K854748", "K071397", "K864005", "K901712", "K202389", "K933081", "K982243", "K134023", "K111885", "K222086", "K033863", "K854509", "K981047", "K812513", "K884084", "K190304", "K240840", "K092636", "K960309", "K833500", "K013472", "K843811", "K822889", "K043520", "K051887", "K071608", "K884581", "K121531", "K844223", "K071461", "K250625", "K063454", "K242718", "K770157", "K203086", "K210371", "K781074", "K250805", "K952037", "K090007", "K792385", "K091650", "K993088", "K182454", "K203210", "K822789", "K872534", "K760704", "K081508", "K924100", "K062153", "K952941", "K211056", "K852209", "K896457", "K850346", "K810272", "K102750", "K834274", "K121167", "K851437", "K040892", "K033405", "K061414", "K160630", "K813018", "K030920", "K823172", "K862194", "K880044", "K072348", "K915381", "K223740", "K984081", "K823582", "K902890", "K251607", "K251130", "K844852", "K972614", "K091541", "K843715", "K813436", "K230969", "K781300", "K842114", "K792149", "K032818", "K871603", "K022684", "K043615", "K870064", "K131016", "K833495", "K120785", "K213825", "K853004", "K042944", "K102245", "K223379", "K873284", "K052396", "K113317", "K172234", "K883837", "K230052", "K252268", "K101154", "K252399", "K020362", "K861012", "K761213", "K043006", "K020386", "K912794", "K091028", "K200496", "K951882", "K053230", "K923650", "K252965", "K083751", "K953815", "K162433", "K091191", "K003472", "K831819", "K890150", "K872470", "K841102", "K991722", "K780020", "K924146", "K014301", "K883591", "K830324", "K071928", "K180837", "K924818", "K053229", "K812693", "K222920", "K760705", "K852144", "K771665", "K230702", "K050430", "K042262", "K873156", "K071904", "K032509", "K801523", "K894384", "K004047", "K260171", "K931355", "K020324", "K855208", "K914488", "K780366", "K242736", "K833938", "K131968", "K121260", "K914916", "K131990", "K881802", "K952268", "K963042", "K941145", "K813058", "K953949", "K081468" ], "registration_number": [ "3008841036", "3017684630", "3004112621", "1319044", "3042507287", "9710644", "1220477", "3010287621", "3011205710", "3007573469", "3033859527", "3009096682", "3009128734", "3014777423", "2183615", "2032532", "3016859940", "3043460907", "3006534178", "3032013079", "3005587132", "3004972304", "3011249646", "3008507279", "3023272766", "3033526676", "3010317211", "3029227324", "3004672275", "3005569927", "3008220943", "3011120183", "3033814505", "3009683397", "3003803075", "3013095415", "3004964590", "3005873568", "3015142815", "3006991053", "2523148", "2028807", "3017608802", "3015772781", "9611451", "2515872", "1924066", "3000126629", "1039215", "3007220521", "3011191255", "2518422", "3043648593", "3019385742", "3025889185", "3005803793", "3017825461", "1000604079", "3018783526", "3023245116", "3017520736", "3007740533", "3002807637", "3007344957", "3008910673", "3006240053", "3016809216", "3003207908", "3037045878", "3012316249", "3011767915", "3045816954", "3011895992", "3027241818", "1419185", "3020476987", "3013000203", "3027605507", "3009550619", "3001400310", "3010440667", "3003637574", "3014661487", "3007307467", "3014810929", "2085602" ], "fei_number": [ "3008841036", "3017684630", "3004112621", "3042507287", "1220477", "3010287621", "3011205710", "3033859527", "3009096682", "3014777423", "2183615", "3016859940", "3043460907", "3006534178", "3032013079", "3005587132", "3004972304", "3011249646", "3008507279", "3023272766", "3033526676", "2129616", "3010317211", "3029227324", "3004672275", "3005569927", "3002806988", "3008220943", "3009843463", "3011120183", "3033814505", "3009683397", "3003803075", "3013095415", "3004964590", "3005873568", "3015142815", "3006991053", "2523148", "3017608802", "3015772781", "2515872", "1924066", "3000126629", "1039215", "3007220521", "3011191255", "1000374126", "2518422", "3002768081", "3043648593", "3025889185", "3005803793", "3017825461", "1000604079", "3018783526", "1000115734", "3023245116", "3017520736", "3007740533", "3002807637", "3007344957", "3000210616", "3008910673", "3006277965", "3006240053", "3016809216", "3003207908", "3037045878", "3012316249", "3011767915", "3003949221", "3045816954", "3011895992", "3027241818", "1419185", "3020476987", "3013000203", "3027605507", "3009550619", "3001400310", "3010440667", "3003637574", "3014661487", "3007307467", "3014810929" ], "device_name": "Generator, Oxygen, Portable", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5440", "device_class": "2" } } ] }