CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine recalled

Fresenius Medical Care Renal Therapies Group is recalling Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, distributed nationwide in the US. The recall was initiated on 30 Jun 2026 and the FDA has classified it as Class II.

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Lot, batch or date codes191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5T0S291145, 5T0S291146, 5T0S291148, 5T0S291149, 5T0S291150, 5T0S291151, 5T0S291152, 5T0S291154, 5T0S291155, 5T0S291156, 5T0S291157, 5T0S291158, 5T0S291159, 5T0S291160, 5T0S291161, 5T0S291162, 5T0S291163, 5T0S291164, 5T0S291165, 5T0S291166, 5T0S291168, 5T0S291169, 5T0S291170, 5T0S291173, 5T0S291177, 5T0S291178, 5T0S291179, 5T0S291180, 5T0S291181, 5T0S291182, 5T0S291183, 5T0S291184, 5T0S291185, 5T0S291186, 5T0S291187, 5T0S291188, 5T0S291189, 5T0S291190, 5T0S291191, 5T0S291192, 5T0S291193, 5T0S291194, 5T0S291195, 5T0S291196, 5T0S291197, 5T0S291198, 5T0S291199, 5T0S291200, 5T0S291201, 5T0S291202, 5T0S291203, 5T0S291204, 5T0S291205, 5T0S291206, 5T0S291207, 5T0S291208, 5T0S291209, 5T0S291210, 5T0S291211, 5T0S291212, 5T0S291213, 5T0S291214, 5T0S291215, 5T0S291216, 5T0S291217, 5T0S291218, 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6T0S292618, 6T0S292619, 6T0S292621, 6T0S292622, 6T0S292623, 6T0S292626, 6T0S292627, 6T0S292628, 6T0S292629, 6T0S292630, 6T0S292633, 6T0S292634, 6T0S292635, 6T0S292636, 6T0S292637, 6T0S292638, 6T0S292639, 6T0S292640, 6T0S292641, 6T0S292642, 6T0S292643, 6T0S292644, 6T0S292645, 6T0S292646, 6T0S292647, 6T0S292648, 6T0S292649, 6T0S292650, 6T0S292651, 6T0S292652, 6T0S292653, 6T0S292654, 6T0S292655, 6T0S292656, 6T0S292657, 6T0S292658, 6T0S292659, 6T0S292660, 6T0S292661, 6T0S292662, 6T0S292663, 6T0S292664, 6T0S292665, 6T0S292666, 6T0S292667, 6T0S292668, 6T0S292669, 6T0S292670, 6T0S292671, 6T0S292672, 6T0S292673, 6T0S292674, 6T0S292675, 6T0S292676, 6T0S292677, 6T0S292678, 6T0S292679, 6T0S292680, 6T0S292681, 6T0S292682, 6T0S292683, 6T0S292684, 6T0S292685, 6T0S292686, 6T0S292687, 6T0S292688, 6T0S292689, 6T0S292690, 6T0S292691, 6T0S292692, 6T0S292693, 6T0S292694, 6T0S292695, 6T0S292696, 6T0S292697, 6T0S292698, 6T0S292699, 6T0S292700, 6T0S292701, 6T0S292702, 6T0S292703, 6T0S292704, 6T0S292705, 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6T0S292804, 6T0S292805, 6T0S292807, 6T0S292808, 6T0S292809, 6T0S292810, 6T0S292811, 6T0S292812, 6T0S292813, 6T0S292814, 6T0S292815, 6T0S292816, 6T0S292817, 6T0S292818, 6T0S292819, 6T0S292820, 6T0S292821, 6T0S292822, 6T0S292823, 6T0S292824, 6T0S292825, 6T0S292826, 6T0S292827, 6T0S292828, 6T0S292829, 6T0S292830, 6T0S292831, 6T0S292832, 6T0S292833, 6T0S292834, 6T0S292835, 6T0S292836, 6T0S292837, 6T0S292838, 6T0S292839, 6T0S292840, 6T0S292841, 6T0S292842, 6T0S292843, 6T0S292845, 6T0S292871, 6T0S292872, 6T0S292873, 6T0S292874, 6T0S292875, 6T0S292876, 6T0S292877, 6T0S292878, 6T0S292879, 6T0S292880, 6T0S292882, 6T0S292883, 6T0S292886, 6T0S292888, 6T0S292890, 6T0S292891, 6T0S292892, 6T0S292894, 6T0S292895, 6T0S292896, 6T0S292898, 6T0S292900, 6T0S292901, 6T0S292902, 6T0S292903, 6T0S292904, 6T0S292905, 6T0S292906, 6T0S292909, 6T0S292910, 6T0S292912, 6T0S292913, 6T0S292917, 6T0S292919, 6T0S292922, 6T0S292925, 6T0S292927, 6T0S292928, 6T0S292929, 6T0S292931, 6T0S292932, 6T0S292935, 6T0S292937, 6T0S292938, 6T0S292940, 6T0S292943, 6T0S292945, 6T0S292946, 6T0S292947, 6T0S292950, 6T0S292951, 6T0S292955, 6T0S292964, 6T0S292967, 6T0S292985, 6T0S293042, 6T0S293059, 6T0S293063, 6T0S293067, 6T0S293082, 6T0S293092, 6T0S293093, 6T0S293094, 6T0S293097, 6T0S293098, 6T0S293099, 6T0S293100, 6T0S293101, 6T0S293102, 6T0S293103, 6T0S293107, 6T0S293108, 6T0S293109, 6T0S293111, 6T0S293112, 6T0S293114, 6T0S293115, 6T0S293116, 6T0S293117, 6T0S293118, 6T0S293119, 6T0S293120, 6T0S293121, 6T0S293122, 6T0S293123, 6T0S293124, 6T0S293125, 6T0S293126, 6T0S293127, 6T0S293128, 6T0S293129, 6T0S293131, 6T0S293132, 6T0S293133, 6T0S293134, 6T0S293135, 6T0S293136, 6T0S293137, 6T0S293138, 6T0S293139, 6T0S293140, 6T0S293141, 6T0S293142, 6T0S293144, 6T0S293145, 6T0S293146, 6T0S293147, 6T0S293148, 6T0S293190, 6T0S293191, 6T0S293198, 6T0S293200, 6T0S293311, 6T0S293317.

Quantity recalled1140 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3017-2026
FDA event ID: 99438
Recalling firm: Fresenius Medical Care Renal Therapies Group, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 30 Jun 2026
FDA classified: 26 Aug 2026
Reported: 2 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

30 Jun 2026	Recall initiated by company
26 Aug 2026	Classified by FDA	+57 days
2 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.

Which lots are affected?

191126, UDI/DI 00840861102099, Serial Numbers: 5T0S291116, 5T0S291119, 5T0S291125, 5T0S291135, 5T0S291137, 5T0S291138, 5T0S291139, 5T0S291140, 5T0S291141, 5T0S291143, 5T0S291144, 5T0S291145, 5T0S291146, 5T0S291148, 5T0S291149, 5T0S291150, 5T0S291151, 5T0S291152, 5T0S291154, 5T0S291155, 5T0S291156, 5T0S291157, 5T0S291158, 5T0S291159, 5T0S291160, 5T0S291161, 5T0S291162, 5T0S291163, 5T0S291164, 5T0S291165, 5T0S291166, 5T0S291168, 5T0S291169, 5T0S291170, 5T0S291173, 5T0S291177, 5T0S291178, 5T0S291179, 5T0S291180, 5T0S291181, 5T0S291182, 5T0S291183, 5T0S291184, 5T0S291185, 5T0S291186, 5T0S291187, 5T0S291188, 5T0S291189, 5T0S291190, 5T0S291191, 5T0S291192, 5T0S291193, 5T0S291194, 5T0S291195, 5T0S291196, 5T0S291197, 5T0S291198, 5T0S291199, 5T0S291200, 5T0S291201, 5T0S291202, 5T0S291203, 5T0S291204, 5T0S291205, 5T0S291206, 5T0S291207, 5T0S291208, 5T0S291209, 5T0S291210, 5T0S291211, 5T0S291212, 5T0S291213, 5T0S291214, 5T0S291215, 5T0S291216, 5T0S291217, 5T0S291218, 5T0S291219, 5T0S291220, 5T0S291221, 5T0S291222, 5T0S291223, 5T0S291224, 5T0S291225, 5T0S291226, 5T0S291228, 5T0S291229, 5T0S291230, 5T0S291231, 5T0S291232, 5T0S291234, 5T0S291235, 5T0S291242, 5T0S291243, 5T0S291244, 5T0S291245, 5T0S291247, 5T0S291248, 5T0S291249, 5T0S291250, 5T0S291251, 5T0S291252, 5T0S291253, 5T0S291314, 5T0S291315, 5T0S291316, 5T0S291317, 5T0S291318, 5T0S291319, 5T0S291320, 5T0S291321, 5T0S291322, 5T0S291323, 5T0S291324, 5T0S291325, 5T0S291326, 5T0S291327, 5T0S291328, 5T0S291329, 5T0S291330, 5T0S291332, 5T0S291333, 5T0S291334, 5T0S291335, 5T0S291337, 5T0S291338, 5T0S291339, 5T0S291340, 5T0S291341, 5T0S291342, 5T0S291343, 5T0S291346, 5T0S291403, 5T0S291407, 5T0S291408, 5T0S291409, 5T0S291410, 5T0S291411, 5T0S291412, 5T0S291413, 5T0S291414, 5T0S291415, 5T0S291416, 5T0S291417, 5T0S291418, 5T0S291421, 5T0S291423, 5T0S291424, 5T0S291425, 5T0S291426, 5T0S291427, 5T0S291428, 5T0S291433, 5T0S291435, 5T0S291436, 5T0S291438, 5T0S291440, 5T0S291441, 5T0S291442, 5T0S291444, 5T0S291446, 5T0S291447, 5T0S291450, 5T0S291452, 5T0S291458, 5T0S291460, 5T0S291461, 5T0S291463, 5T0S291464, 5T0S291466, 5T0S291467, 5T0S291472, 5T0S291474, 5T0S291476, 5T0S291479, 5T0S291480, 5T0S291526, 5T0S291556, 5T0S291584, 6T0S292446, 6T0S292448, 6T0S292460, 6T0S292461, 6T0S292463, 6T0S292464, 6T0S292465, 6T0S292466, 6T0S292467, 6T0S292468, 6T0S292469, 6T0S292470, 6T0S292471, 6T0S292472, 6T0S292473, 6T0S292474, 6T0S292475, 6T0S292476, 6T0S292477, 6T0S292478, 6T0S292479, 6T0S292480, 6T0S292481, 6T0S292482, 6T0S292483, 6T0S292484, 6T0S292485, 6T0S292486, 6T0S292487, 6T0S292488, 6T0S292489, 6T0S292490, 6T0S292491, 6T0S292492, 6T0S292493, 6T0S292494, 6T0S292495, 6T0S292496, 6T0S292498, 6T0S292499, 6T0S292500, 6T0S292501, 6T0S292502, 6T0S292503, 6T0S292504, 6T0S292505, 6T0S292506, 6T0S292507, 6T0S292508, 6T0S292509, 6T0S292510, 6T0S292511, 6T0S292512, 6T0S292513, 6T0S292514, 6T0S292515, 6T0S292516, 6T0S292517, 6T0S292518, 6T0S292519, 6T0S292520, 6T0S292521, 6T0S292522, 6T0S292523, 6T0S292524, 6T0S292525, 6T0S292526. 191130, UDI/DI 00840861102112, Serial Numbers: 6T0S291719, 6T0S291816, 6T0S291842, 6T0S291844, 6T0S291850, 6T0S291856, 6T0S291857, 6T0S291859, 6T0S291861, 6T0S291874, 6T0S291884, 6T0S291893, 6T0S291899, 6T0S291901, 6T0S291902, 6T0S291903, 6T0S291904, 6T0S291905, 6T0S291906, 6T0S291907, 6T0S291908, 6T0S291909, 6T0S291910, 6T0S291911, 6T0S291912, 6T0S291913, 6T0S291914, 6T0S291915, 6T0S291916, 6T0S291917, 6T0S291918, 6T0S291919, 6T0S291920, 6T0S291921, 6T0S291922, 6T0S291923, 6T0S291924, 6T0S291925, 6T0S291926, 6T0S291927, 6T0S291928, 6T0S291929, 6T0S291930, 6T0S291931, 6T0S291932, 6T0S291933, 6T0S291934, 6T0S291935, 6T0S291936, 6T0S291937, 6T0S291938, 6T0S291939, 6T0S291940, 6T0S291941, 6T0S291942, 6T0S291943, 6T0S291944, 6T0S291945, 6T0S291946, 6T0S291947, 6T0S291948, 6T0S291949, 6T0S291950, 6T0S291951, 6T0S291952, 6T0S291953, 6T0S291954, 6T0S291955, 6T0S291956, 6T0S291957, 6T0S291958, 6T0S291959, 6T0S291960, 6T0S291961, 6T0S291962, 6T0S291963, 6T0S291964, 6T0S291965, 6T0S291966, 6T0S291967, 6T0S291968, 6T0S291969, 6T0S291970, 6T0S291971, 6T0S291972, 6T0S291973, 6T0S291974, 6T0S291975, 6T0S291976, 6T0S291977, 6T0S291978, 6T0S291979, 6T0S291980, 6T0S291981, 6T0S291982, 6T0S291983, 6T0S291984, 6T0S291985, 6T0S291986, 6T0S291987, 6T0S291988, 6T0S291989, 6T0S291990, 6T0S291991, 6T0S291992, 6T0S291993, 6T0S291994, 6T0S291995, 6T0S291996, 6T0S291997, 6T0S291998, 6T0S291999, 6T0S292000, 6T0S292001, 6T0S292002, 6T0S292003, 6T0S292004, 6T0S292005, 6T0S292006, 6T0S292007, 6T0S292008, 6T0S292009, 6T0S292010, 6T0S292042, 6T0S292043, 6T0S292044, 6T0S292045, 6T0S292046, 6T0S292047, 6T0S292048, 6T0S292049, 6T0S292050, 6T0S292051, 6T0S292052, 6T0S292053, 6T0S292054, 6T0S292055, 6T0S292056, 6T0S292057, 6T0S292058, 6T0S292059, 6T0S292060, 6T0S292061, 6T0S292062, 6T0S292063, 6T0S292064, 6T0S292065, 6T0S292066, 6T0S292067, 6T0S292069, 6T0S292074, 6T0S292075, 6T0S292076, 6T0S292077, 6T0S292079, 6T0S292080, 6T0S292081, 6T0S292082, 6T0S292083, 6T0S292084, 6T0S292085, 6T0S292087, 6T0S292088, 6T0S292089, 6T0S292090, 6T0S292091, 6T0S292092, 6T0S292093, 6T0S292094, 6T0S292095, 6T0S292096, 6T0S292097, 6T0S292098, 6T0S292099, 6T0S292100, 6T0S292101, 6T0S292102, 6T0S292103, 6T0S292104, 6T0S292105, 6T0S292106, 6T0S292107, 6T0S292108, 6T0S292109, 6T0S292110, 6T0S292111, 6T0S292112, 6T0S292113, 6T0S292114, 6T0S292115, 6T0S292116, 6T0S292117, 6T0S292118, 6T0S292119, 6T0S292120, 6T0S292121, 6T0S292122, 6T0S292123, 6T0S292124, 6T0S292125, 6T0S292126, 6T0S292127, 6T0S292128, 6T0S292129, 6T0S292130, 6T0S292131, 6T0S292132, 6T0S292133, 6T0S292134, 6T0S292135, 6T0S292136, 6T0S292137, 6T0S292138, 6T0S292139, 6T0S292140, 6T0S292141, 6T0S292142, 6T0S292143, 6T0S292144, 6T0S292145, 6T0S292146, 6T0S292147, 6T0S292148, 6T0S292149, 6T0S292150, 6T0S292151, 6T0S292152, 6T0S292153, 6T0S292154, 6T0S292155, 6T0S292156, 6T0S292157, 6T0S292158, 6T0S292159, 6T0S292160, 6T0S292161, 6T0S292162, 6T0S292163, 6T0S292164, 6T0S292165, 6T0S292166, 6T0S292167, 6T0S292168, 6T0S292169, 6T0S292170, 6T0S292171, 6T0S292172, 6T0S292173, 6T0S292174, 6T0S292175, 6T0S292176, 6T0S292177, 6T0S292178, 6T0S292179, 6T0S292180, 6T0S292181, 6T0S292182, 6T0S292183, 6T0S292184, 6T0S292185, 6T0S292186, 6T0S292187, 6T0S292188, 6T0S292189, 6T0S292190, 6T0S292191, 6T0S292192, 6T0S292193, 6T0S292194, 6T0S292195, 6T0S292196, 6T0S292197, 6T0S292198, 6T0S292199, 6T0S292200, 6T0S292201, 6T0S292202, 6T0S292203, 6T0S292204, 6T0S292205, 6T0S292206, 6T0S292207, 6T0S292208, 6T0S292209, 6T0S292210, 6T0S292211, 6T0S292212, 6T0S292213, 6T0S292214, 6T0S292215, 6T0S292216, 6T0S292217, 6T0S292218, 6T0S292219, 6T0S292220, 6T0S292221, 6T0S292222, 6T0S292223, 6T0S292224, 6T0S292234, 6T0S292235, 6T0S292236, 6T0S292237, 6T0S292238, 6T0S292239, 6T0S292240, 6T0S292241, 6T0S292242, 6T0S292243, 6T0S292244, 6T0S292245, 6T0S292246, 6T0S292247, 6T0S292248, 6T0S292249, 6T0S292250, 6T0S292251, 6T0S292252, 6T0S292253, 6T0S292254, 6T0S292255, 6T0S292256, 6T0S292257, 6T0S292258, 6T0S292259, 6T0S292260, 6T0S292261, 6T0S292262, 6T0S292263, 6T0S292264, 6T0S292265, 6T0S292266, 6T0S292267, 6T0S292268, 6T0S292269, 6T0S292270, 6T0S292271, 6T0S292272, 6T0S292273, 6T0S292274, 6T0S292275, 6T0S292276, 6T0S292277, 6T0S292278, 6T0S292279, 6T0S292280, 6T0S292281, 6T0S292282, 6T0S292283, 6T0S292284, 6T0S292285, 6T0S292286, 6T0S292287, 6T0S292288, 6T0S292289, 6T0S292290, 6T0S292291, 6T0S292292, 6T0S292293, 6T0S292294, 6T0S292295, 6T0S292296, 6T0S292297, 6T0S292298, 6T0S292299, 6T0S292300, 6T0S292301, 6T0S292302, 6T0S292303, 6T0S292304, 6T0S292305, 6T0S292306, 6T0S292307, 6T0S292308, 6T0S292309, 6T0S292310, 6T0S292311, 6T0S292312, 6T0S292313, 6T0S292314, 6T0S292315, 6T0S292316, 6T0S292317, 6T0S292318, 6T0S292339, 6T0S292340, 6T0S292341, 6T0S292342, 6T0S292343, 6T0S292344, 6T0S292345, 6T0S292346, 6T0S292347, 6T0S292348, 6T0S292349, 6T0S292350, 6T0S292351, 6T0S292352, 6T0S292353, 6T0S292354, 6T0S292355, 6T0S292356, 6T0S292357, 6T0S292358, 6T0S292359, 6T0S292360, 6T0S292361, 6T0S292362, 6T0S292363, 6T0S292364, 6T0S292365, 6T0S292366, 6T0S292367, 6T0S292368, 6T0S292369, 6T0S292370, 6T0S292371, 6T0S292372, 6T0S292373, 6T0S292374, 6T0S292375, 6T0S292376, 6T0S292377, 6T0S292378, 6T0S292379, 6T0S292380, 6T0S292381, 6T0S292382, 6T0S292383, 6T0S292384, 6T0S292385, 6T0S292386, 6T0S292387, 6T0S292388, 6T0S292389, 6T0S292390, 6T0S292391, 6T0S292392, 6T0S292393, 6T0S292394, 6T0S292395, 6T0S292396, 6T0S292397, 6T0S292398, 6T0S292399, 6T0S292400, 6T0S292401, 6T0S292402, 6T0S292404, 6T0S292405, 6T0S292406, 6T0S292407, 6T0S292408, 6T0S292409, 6T0S292410, 6T0S292411, 6T0S292412, 6T0S292413, 6T0S292414, 6T0S292415, 6T0S292416, 6T0S292417, 6T0S292418, 6T0S292419, 6T0S292420, 6T0S292421, 6T0S292422, 6T0S292423, 6T0S292424, 6T0S292425, 6T0S292426, 6T0S292427, 6T0S292428, 6T0S292429, 6T0S292430, 6T0S292431, 6T0S292432, 6T0S292433, 6T0S292434, 6T0S292435, 6T0S292436, 6T0S292437, 6T0S292438, 6T0S292439, 6T0S292440, 6T0S292441, 6T0S292442, 6T0S292443, 6T0S292444, 6T0S292445, 6T0S292447, 6T0S292449, 6T0S292450, 6T0S292452, 6T0S292453, 6T0S292454, 6T0S292455, 6T0S292456, 6T0S292457, 6T0S292459, 6T0S292462, 6T0S292497, 6T0S292527, 6T0S292528, 6T0S292529, 6T0S292530, 6T0S292531, 6T0S292532, 6T0S292533, 6T0S292534, 6T0S292535, 6T0S292536, 6T0S292537, 6T0S292538, 6T0S292539, 6T0S292540, 6T0S292541, 6T0S292542, 6T0S292543, 6T0S292544, 6T0S292545, 6T0S292546, 6T0S292547, 6T0S292548, 6T0S292549, 6T0S292551, 6T0S292552, 6T0S292553, 6T0S292554, 6T0S292556, 6T0S292557, 6T0S292558, 6T0S292560, 6T0S292561, 6T0S292562, 6T0S292564, 6T0S292566, 6T0S292567, 6T0S292569, 6T0S292570, 6T0S292571, 6T0S292573, 6T0S292575, 6T0S292576, 6T0S292577, 6T0S292578, 6T0S292579, 6T0S292580, 6T0S292581, 6T0S292582, 6T0S292583, 6T0S292584, 6T0S292585, 6T0S292588, 6T0S292589, 6T0S292591, 6T0S292592, 6T0S292594, 6T0S292596, 6T0S292597, 6T0S292598, 6T0S292599, 6T0S292600, 6T0S292601, 6T0S292605, 6T0S292607, 6T0S292608, 6T0S292609, 6T0S292611, 6T0S292612, 6T0S292613, 6T0S292614, 6T0S292615, 6T0S292616, 6T0S292618, 6T0S292619, 6T0S292621, 6T0S292622, 6T0S292623, 6T0S292626, 6T0S292627, 6T0S292628, 6T0S292629, 6T0S292630, 6T0S292633, 6T0S292634, 6T0S292635, 6T0S292636, 6T0S292637, 6T0S292638, 6T0S292639, 6T0S292640, 6T0S292641, 6T0S292642, 6T0S292643, 6T0S292644, 6T0S292645, 6T0S292646, 6T0S292647, 6T0S292648, 6T0S292649, 6T0S292650, 6T0S292651, 6T0S292652, 6T0S292653, 6T0S292654, 6T0S292655, 6T0S292656, 6T0S292657, 6T0S292658, 6T0S292659, 6T0S292660, 6T0S292661, 6T0S292662, 6T0S292663, 6T0S292664, 6T0S292665, 6T0S292666, 6T0S292667, 6T0S292668, 6T0S292669, 6T0S292670, 6T0S292671, 6T0S292672, 6T0S292673, 6T0S292674, 6T0S292675, 6T0S292676, 6T0S292677, 6T0S292678, 6T0S292679, 6T0S292680, 6T0S292681, 6T0S292682, 6T0S292683, 6T0S292684, 6T0S292685, 6T0S292686, 6T0S292687, 6T0S292688, 6T0S292689, 6T0S292690, 6T0S292691, 6T0S292692, 6T0S292693, 6T0S292694, 6T0S292695, 6T0S292696, 6T0S292697, 6T0S292698, 6T0S292699, 6T0S292700, 6T0S292701, 6T0S292702, 6T0S292703, 6T0S292704, 6T0S292705, 6T0S292706, 6T0S292707, 6T0S292708, 6T0S292709, 6T0S292710, 6T0S292711, 6T0S292712, 6T0S292713, 6T0S292714, 6T0S292715, 6T0S292716, 6T0S292717, 6T0S292721, 6T0S292722, 6T0S292723, 6T0S292724, 6T0S292725, 6T0S292727, 6T0S292728, 6T0S292729, 6T0S292730, 6T0S292731, 6T0S292732, 6T0S292733, 6T0S292734, 6T0S292735, 6T0S292737, 6T0S292739, 6T0S292742, 6T0S292745, 6T0S292747, 6T0S292748, 6T0S292749, 6T0S292751, 6T0S292752, 6T0S292753, 6T0S292754, 6T0S292755, 6T0S292756, 6T0S292757, 6T0S292758, 6T0S292759, 6T0S292760, 6T0S292763, 6T0S292764, 6T0S292765, 6T0S292766, 6T0S292767, 6T0S292768, 6T0S292769, 6T0S292770, 6T0S292771, 6T0S292772, 6T0S292773, 6T0S292774, 6T0S292775, 6T0S292776, 6T0S292777, 6T0S292778, 6T0S292779, 6T0S292780, 6T0S292781, 6T0S292782, 6T0S292783, 6T0S292785, 6T0S292786, 6T0S292787, 6T0S292788, 6T0S292789, 6T0S292790, 6T0S292791, 6T0S292792, 6T0S292793, 6T0S292794, 6T0S292795, 6T0S292796, 6T0S292797, 6T0S292798, 6T0S292799, 6T0S292800, 6T0S292801, 6T0S292802, 6T0S292803, 6T0S292804, 6T0S292805, 6T0S292807, 6T0S292808, 6T0S292809, 6T0S292810, 6T0S292811, 6T0S292812, 6T0S292813, 6T0S292814, 6T0S292815, 6T0S292816, 6T0S292817, 6T0S292818, 6T0S292819, 6T0S292820, 6T0S292821, 6T0S292822, 6T0S292823, 6T0S292824, 6T0S292825, 6T0S292826, 6T0S292827, 6T0S292828, 6T0S292829, 6T0S292830, 6T0S292831, 6T0S292832, 6T0S292833, 6T0S292834, 6T0S292835, 6T0S292836, 6T0S292837, 6T0S292838, 6T0S292839, 6T0S292840, 6T0S292841, 6T0S292842, 6T0S292843, 6T0S292845, 6T0S292871, 6T0S292872, 6T0S292873, 6T0S292874, 6T0S292875, 6T0S292876, 6T0S292877, 6T0S292878, 6T0S292879, 6T0S292880, 6T0S292882, 6T0S292883, 6T0S292886, 6T0S292888, 6T0S292890, 6T0S292891, 6T0S292892, 6T0S292894, 6T0S292895, 6T0S292896, 6T0S292898, 6T0S292900, 6T0S292901, 6T0S292902, 6T0S292903, 6T0S292904, 6T0S292905, 6T0S292906, 6T0S292909, 6T0S292910, 6T0S292912, 6T0S292913, 6T0S292917, 6T0S292919, 6T0S292922, 6T0S292925, 6T0S292927, 6T0S292928, 6T0S292929, 6T0S292931, 6T0S292932, 6T0S292935, 6T0S292937, 6T0S292938, 6T0S292940, 6T0S292943, 6T0S292945, 6T0S292946, 6T0S292947, 6T0S292950, 6T0S292951, 6T0S292955, 6T0S292964, 6T0S292967, 6T0S292985, 6T0S293042, 6T0S293059, 6T0S293063, 6T0S293067, 6T0S293082, 6T0S293092, 6T0S293093, 6T0S293094, 6T0S293097, 6T0S293098, 6T0S293099, 6T0S293100, 6T0S293101, 6T0S293102, 6T0S293103, 6T0S293107, 6T0S293108, 6T0S293109, 6T0S293111, 6T0S293112, 6T0S293114, 6T0S293115, 6T0S293116, 6T0S293117, 6T0S293118, 6T0S293119, 6T0S293120, 6T0S293121, 6T0S293122, 6T0S293123, 6T0S293124, 6T0S293125, 6T0S293126, 6T0S293127, 6T0S293128, 6T0S293129, 6T0S293131, 6T0S293132, 6T0S293133, 6T0S293134, 6T0S293135, 6T0S293136, 6T0S293137, 6T0S293138, 6T0S293139, 6T0S293140, 6T0S293141, 6T0S293142, 6T0S293144, 6T0S293145, 6T0S293146, 6T0S293147, 6T0S293148, 6T0S293190, 6T0S293191, 6T0S293198, 6T0S293200, 6T0S293311, 6T0S293317.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Fresenius Medical Care Renal Therapies Group

All 34

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	5008X HD/HDF with CLiC Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	5008X HD/HDF Standard Blood Tubing Set recalled	Fresenius Medical Care Renal Therapies Group	Packaging Defects	Nationwide
9 Sep 2026Device	CLASS II	Citrasate, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	NaturaLyte, Liquid Acid Concentrate recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide
9 Sep 2026Device	CLASS II	Granuflo Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled	Fresenius Medical Care Renal Therapies Group	Other	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide