2008T BlueStar Hemodialysis Machine recallZ-3017-2026 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Jun 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
Fresenius Medical Care issued an URGENT MEDICAL DEVICDE CORRECTION notice to its consignees on 7/15/2026 via USPS First Class Mail. The notice explained the issue, potential risk and requested the following: "What to do at this time: 1. If your affected 2008T BlueStar machine is in use, and you are not experiencing error messages, you may continue to use it until the parts are replaced. 2. If your affected 2008T BlueStar machine experiences flow-, no water-, or temperature-related alarms, please use a back-up machine until FMCRTG can replace the parts in the affected machine. 3. If your affected 2008T BlueStar machine(s) has not yet been installed at your clinic, FMCRTG will replace the parts before installation. To correct your machine(s), please contact FMCRTG Technical Service between 8:00 AM 5:00 PM Eastern daily, at 1-800-227-2572, and select Option 4, followed by Option 2, to be connected with the appropriate support representative to schedule your update, or if you have any further questions." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Recall details
- Recall number
- Z-3017-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 30, 2026
- Posted by the FDA
- Aug 26, 2026
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 1140 systems
- Product code
- KDI
- FDA submissions
- K243237
- Distribution
- US Nationwide distribution.
Product description
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Code information (models, lots, serial numbers)
Show the full code information (14k characters)
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, 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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.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K243237 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 2008T BlueStar Hemodialysis Machine 191124Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls32 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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