Fresenius Medical Care Renal Therapies Group recall: Fresenius Medical Care

Fresenius Medical Care Renal Therapies Group, LLC is recalling Fresenius Medical Care – 1140 systems. The U.S. Food and Drug Administration published the recall on September 2, 2026; it began on June 30, 2026. Distributed nationwide.

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

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

   FDA recall number

   Z-3017-2026

   Codes, lots and dates

   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, 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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.

   Quantity

   1140 systems

   Classification

   Class II

FDA event ID

99438

Initiated

Voluntary: Firm initiated

Status

Ongoing

Firm location

Waltham, MA, United States

Date	Recall	Problem	Agency
Sep 30, 2026	Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsMedical devices · 1743026 units	Communication to recommend reviewing the IFU and ensuring that all treatment preparation a… Serious	FDA Class II
Sep 9, 2026	Fresenius Medical Care Renal Therapies Group recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more productsMedical devices · 27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 ea	Complaints of blue-green discoloration in product Serious	FDA Class II
Sep 9, 2026	Fresenius Medical Care Renal Therapies Group recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more productsMedical devices · 120 units; 62,544 units; 18,600; 6,624 units	Heightened probability of blood leak from the connection between the Arterial Alpha Clip a… Serious	FDA Class II

All 4 Fresenius Medical Care Renal Therapies Group recalls →

Date	Recall	Problem	Agency
Oct 7, 2026	Draeger recall: VentStar Resus NeoMedical devices · 1,063,643 units	Potential cracks in the hose, which could lead to leakage or the hose falling off. Most serious	FDA Class I
Oct 7, 2026	Medline Industries recall: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories and 1 more productMedical devices · 771,127 total	a fire hazard Most serious	FDA Class I
Oct 7, 2026	Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces	Due to incorrect inside packaging label for eyepiece. Serious	FDA Class II
Oct 7, 2026	Noxbox recall: NOxBOXi Nitric Oxide Delivery SystemMedical devices · 1,667 units	Potential for irregular oxygen readings due to a manufacturing issue affecting certain oxy… Serious	FDA Class II
Oct 7, 2026	Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS)	The potential for falsely elevated results. Serious	FDA Class II
Oct 7, 2026	Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177	A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious	FDA Class II

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.