Fresenius Medical Care Renal Therapies Group, LLC: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Recall number

Z-3017-2026

Recalling firm

Fresenius Medical Care Renal Therapies Group, LLC

Product

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

Status

Open, Classified

Initiated

2026-06-30

Posted

2026-08-26

Terminated

not on file

Reason

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.

Root cause

Process control

Action

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.

Quantity

1140 systems

Distribution

US Nationwide distribution.

Lot, serial or model codes

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, 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510(k) numbers

["K243237"]

PMA numbers

not on file

Product code

KDI

Firm FEI

3001451489

Firm city

Waltham

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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