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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95576

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 04, 2024
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Caire, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.

Z-0478-2025
Recall number
Z-0478-2025
Initiated
October 04, 2024
Classification
Class II
Status
Completed
Recalling firm
Caire, Inc.
Quantity
739 concentrators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure of affected units to recharge the battery of the oxygen concentrators.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Code information

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.

Distribution pattern

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

device · product 2 of 4

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.

Z-0479-2025
Recall number
Z-0479-2025
Initiated
October 04, 2024
Classification
Class II
Status
Completed
Recalling firm
Caire, Inc.
Quantity
23 concentrators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure of affected units to recharge the battery of the oxygen concentrators.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Code information

UDI-DI: M766AS2001010; Serial numbers: CBB5224380888, CBB5224380868, CBB5224380846, CBB5224380842, CBB5224380298, CBB5224380295, CBB5224380282, CBB5224380251, CBB5224380011, CBB5224380010, CBB5224370651, CBB5224370598, CBB5224370445, CBB5224370431, CBB5224370420, CBB5224370230, CBB5224370227, CBB5224370191, CBB5224370185, CBB5224370168, CBB5224370165, CBB5224370009, and CBB5224350790.

Distribution pattern

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

device · product 3 of 4

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.

Z-0480-2025
Recall number
Z-0480-2025
Initiated
October 04, 2024
Classification
Class II
Status
Completed
Recalling firm
Caire, Inc.
Quantity
6 concentrators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure of affected units to recharge the battery of the oxygen concentrators.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Code information

No UDI-DI (for export only); Serial numbers CBB5224350751, CBB5224350720, CBB5224350604, CBB5224350601, CBB5224350598, and CBB5224350582.

Distribution pattern

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.

device · product 4 of 4

CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.

Z-0481-2025
Recall number
Z-0481-2025
Initiated
October 04, 2024
Classification
Class II
Status
Completed
Recalling firm
Caire, Inc.
Quantity
26 concentrators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure of affected units to recharge the battery of the oxygen concentrators.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure of affected units to recharge the battery of the oxygen concentrators.

Code information

No UDI-DI (for export only); Serial numbers: CBB5224350777, CBB5224350774, CBB5224350743, CBB5224350723, CBB5224350710, CBB5224350653, CBB5224350648, CBB5224350636, CBB5224350606, CBB5224350583, CBB5224350580, CBB5224350575, CBB5224350573, CBB5224350567, CBB5224350512, CBB5224350510, CBB5224350509, CBB5224350508, CBB5224350498, CBB5224350492, CBB5224350490, CBB5224350475, CBB5224350474, CBB5224350468, CBB5224350460, and CBB5224350459.

Distribution pattern

Worldwide distribution - US Nationwide, including PR and the countries of Israel and Peru.