Class 2 Device Recall Fresenius Medical Care

• Date Initiated by Firm: June 30, 2026
• Date Posted: August 26, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3017-2026
• Recall Event ID: 99438
• 510(K)Number: K243237
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
• Code Information: 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, 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• FEI Number: 3001451489
• Recalling Firm/ Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC; 920 Winter St Bld 920; Waltham MA 02451-1521
• For Additional Information Contact: Fresenius Medical Care Customer Service; 800-323-5188
• Manufacturer 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.
• FDA Determined 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 in Commerce: 1140 systems
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KDI