Class IIDeviceOngoing

Fresenius Medical Care Renal Therapies Group, LLC

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

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.

Details

Recall number: Z-3017-2026
Event ID: 99438
Recall initiated: Jun 30, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 1140 systems
Distribution: US Nationwide distribution.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Waltham, MA, United States
Lot / code info: 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, 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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.