Lower risk Medical device recall · FDA · Published June 3, 2024

Fresenius Medical: 2008K@HOME Blood Pump Rotor Spare Part Recall - Loose Guide Sheaves

Fresenius Medical recalls blood pump rotor spare parts (Model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics. Affected units have specific serial numbers and model identifiers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2344-2024Medical device Fresenius Medical ›

Lower-risk recall

An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical is recalling blood pump rotor spare parts for the 2008K@HOME machine. Clinics reported loose or dislodged guide sheaves after use, which could lead to mechanical failure in blood pumps. Read more at govinfonow.com/recall/54931-fresenius-medical-2008k-home-blood-pump-rotor-spare-part-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/54931-fresenius-medical-2008k-home-blood-pump-rotor-spare-part-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2344-2024

Cite this page

“Fresenius Medical: 2008K@HOME Blood Pump Rotor Spare Part Recall - Loose Guide Sheaves.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54931-fresenius-medical-2008k-home-blood-pump-rotor-spare-part-recall. Based on FDA recall #Z-2344-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2344-2024%22&limit=1).

The FDA announced on June 3, 2024, that Fresenius Medical Care Holdings Inc. is voluntarily recalling the Blood Pump Rotor spare part, Model Number F40015481 Rev A, due to loose or dislodged guide sheaves after use. The agency issued recall number Z-2344-2024 for the Class II device.

How to tell if you have it

Brand: Fresenius Medical
Product: Blood Pump Rotor spare part (RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP)
Model Number: F40015481 Rev A
Model Number: RTL190395 (Rental Units)
UDI/DI: 00840861100958
Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L
Quantity: 17 Units
Distribution: Domestic (Nationwide) and Canada

The hazard

An increased number of complaints were reported on the Blood Pump Rotor after a period of use by clinics noting loose or dislodged guide sheaves. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Fresenius Medical Care Holdings Inc. has 44 other recalls on record since April 14, 2014. Recent recalls include a May 12, 2026 notice for Bicarby Dialysate leaks risk and a May 11, 2026 recall for the 5008X Blood Tubing Set regarding online port errors. Other recent recalls of similar products include the August 10, 2026 Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall and the July 29, 2026 CombiSet Hemodialysis Tubing Set Recall.

How to tell if you have this one

Check if your blood pump rotor spare part has the model number F40015481 Rev A. Affected units include specific serial numbers listed in the recall notice.

Brand
Fresenius Medical
Category
Medical device

FDA recall event · 8 products

All 8 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Domestic: Nationwide Distribution. International: Canada.

Recall number	Product, codes & lots	Quantity
Z-2340-2024	190904 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: 190904; UDI/DI: 00840861100965; Serial Numbers: 5K0S194173, 7K0S300085, 4K0S190310, 4K0S190311, 4K0S190312, 4K0S190314, 4K0S190315, 4K0S190318, 4K0S190321, 4K0S192510, 4K0S192511, 4K0S192812, 4K0S192813, 4K0S192814, 4K0S192815, 4K0S192816, 4K0S192817, 4K0S192818, 4K0S192819, 4K0S192820, 4K0S192821, 4K0S192822, 4K0S192823, 4K0S192824, 4K0S192825, 4K0S192826, 4K0S192827, 4K0S192828, 4K0S192829, 4K0S192830, 4K0S192831, 4K0S192832, 5K0S194166, 5K0S194176, 6K0S172023, 7K0S300011, 7K0S300034, 6K0S172010, 7K0S300092, 7K0S300105, 7K0S300067, 7K0S300074, 7K0S300069, 6K0S172008, 5K0S194162, 6K0S163684, 6K0S172021, 7K0S300019, 7K0S300062, 7K0S300016, 7K0S300027, 6K0S171203, 6K0S169446, 6K0S159427, 6K0S167051, 5K0S193166, 5K0S194156, 6K0S167044, 6K0S167045, 6K0S167049, 6K0S159417, 6K0S165409, 5K0S194145, 6K0S169433, 5K0S193324, 5K0S193676, 6K0S165407, 5K0S193147, 5K0S193677, 6K0S171200, 6K0S167035, 5K0S193312, 6K0S159423, 6K0S159430, 6K0S165412, 6K0S169448, 6K0S172019, 7K0S300009, 7K0S300012, 7K0S300006, 7K0S300007, 7K0S300013, 7K0S300025, 6K0S169442, 5K0S193318, 6K0S162829, 6K0S163670, 6K0S171205, 5K0S194159, 5K0S194169, 5K0S194167, 5K0S194172, 6K0S172022, 5K0S194178, 5K0S193319, 7K0S300040, 6K0S172001, 7K0S300044, 7K0S300060, 5K0S193161, 5K0S193162, 5K0S193165, 5K0S193167, 5K0S193146, 5K0S193151, 5K0S193159, 5K0S193313, 5K0S193332, 5K0S193314, 5K0S193317, 5K0S193326, 5K0S193678, 6K0S162830, 6K0S162834, 6K0S162837, 6K0S162842, 6K0S162844, 6K0S162840, 6K0S162845, 7K0S300032, 7K0S300031, 7K0S300059, 7K0S300017, 7K0S300066, 6K0S163669, 5K0S193667, 5K0S193669, 5K0S193670, 5K0S193672, 5K0S193674, 5K0S193675, 5K0S194147, 5K0S194152, 5K0S194154, 5K0S194177, 6K0S169444, 6K0S172007, 6K0S165410, 6K0S167031, 6K0S171195, 6K0S171197, 6K0S171209, 5K0S194180, 7K0S300024, 5K0S193169, 6K0S169447, 6K0S169440, 6K0S172012, 6K0S172017, 6K0S159418, 6K0S169462, 6K0S167042, 7K0S300053, 6K0S167040, 6K0S167041, 4K0S190313, 5K0S194158, 6K0S171201, 6K0S169436, 5K0S193315, 7K0S300014, 6K0S162835, 6K0S162836, 6K0S167034, 6K0S167052, 7K0S300091, 6K0S159428, 5K0S194153, 5K0S193336, 6K0S169438, 6K0S169450, 7K0S300043, 5K0S194160, 7K0S300071, 7K0S300005, 6K0S172011, 6K0S169452, 6K0S172005, 5K0S193144, 7K0S300058, 5K0S193328, 6K0S159421, 5K0S194163, 6K0S169449, 6K0S169453, 6K0S171204, 7K0S300010, 7K0S300089, 6K0S163668, 6K0S159424, 6K0S159431, 6K0S167037, 5K0S193665, 7K0S300028, 5K0S193160, 6K0S167039, 7K0S300093, 7K0S300095, 6K0S163674, 7K0S300022, 5K0S193163, 5K0S194148, 6K0S172018, 6K0S165414, 6K0S163672, 6K0S163681, 6K0S163676, 6K0S163680, 6K0S169437, 7K0S300035, 5K0S193152, 6K0S159420, 6K0S169439, 6K0S169464, 6K0S171198, 6K0S171206, 6K0S171999, 6K0S172016, 6K0S172020, 6K0S169457, 6K0S172002, 6K0S172013, 6K0S162833, 6K0S165411, 6K0S165413, 7K0S300102, 7K0S300033, 5K0S194150, 6K0S162832, 6K0S169445, 5K0S193168, 5K0S194149, 6K0S163682, 6K0S162839, 6K0S167047, 6K0S171196, 5K0S194157, 5K0S193334, 7K0S300103, 6K0S169434, 6K0S162831, 6K0S163673, 6K0S172014, 6K0S163675, 6K0S163685, 7K0S300021, 6K0S163666, 5K0S193154, 5K0S193325, 6K0S165408, 5K0S193143, 5K0S193158, 5K0S194168, 7K0S300078, 5K0S193149, 5K0S193157, 5K0S193170, 7K0S300030, 5K0S193323, 5K0S193331, 7K0S300107, 6K0S159419, 6K0S159426, 6K0S169456, 7K0S300087, 7K0S300075, 5K0S194151, 6K0S163686, 7K0S300029, 5K0S193156, 5K0S193164, 6K0S169460, 6K0S167043, 6K0S167048, 6K0S167050, 6K0S169465, 7K0S300070, 7K0S300068, 6K0S167053, 6K0S167033, 6K0S167055, 6K0S167032, 5K0S193171, 5K0S193172, 6K0S169443, 6K0S167046, 7K0S300042, 5K0S194171, 4K0S190319, 5K0S193330, 5K0S193153, 5K0S193671, 5K0S194175, 6K0S169466, 6K0S169467, 6K0S171995, 6K0S172003, 6K0S169461, 6K0S171202, 6K0S171210, 6K0S171199, 6K0S171207, 6K0S171211, 6K0S172009, 5K0S193333, 6K0S163667, 6K0S163671, 6K0S172015, 6K0S171996, 6K0S171997, 5K0S193316, 6K0S163679, 6K0S172000, 7K0S300072, 7K0S300100, 7K0S300008, 7K0S300020, 7K0S300026, 6K0S171998, 5K0S193335, 5K0S194165, 6K0S162827, 6K0S162828, 6K0S162838, 6K0S162843, 5K0S193329, 5K0S193148, 5K0S193145, 5K0S193150, 6K0S162841, 5K0S193668, 6K0S159416, 6K0S162846, 6K0S167038, 5K0S194170, 4K0S190309, 5K0S193155, 5K0S193679, 5K0S194155, 6K0S169454, 6K0S169463, 6K0S159422, 6K0S159425, 6K0S169435, 6K0S167054, 6K0S172006, 6K0S172024, 6K0S171208, 6K0S172004, 6K0S169451, 6K0S163678, 7K0S300047, 7K0S300051, 7K0S300054, 7K0S300064, 7K0S300065, 7K0S300076, 7K0S300098, 6K0S169459, 6K0S167036, 6K0S169455, 5K0S193321, 5K0S193666, 5K0S193673, 7K0S300106, 7K0S300104, 6K0S167030, 7K0S300041, 7K0S300050, 7K0S300052, 7K0S300057, 7K0S300090,	372 units
Z-2341-2024	190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: 190828; UDI/DI: 00840861100941; Serial Numbers: 2K0S179489, 3K0S184885, 3K0S185744, 1K0S172050, 1K0S172202, 1K0S171823, 1K0S172056, 3K0S185989, 3K0S186038, 4K0S190849, 4K0S191132, 1K0S171846, 4K0S192532, 4K0S192534, 4K0S192232, 4K0S191583, 2K0S180629, 3K0S185738, 4K0S190517, 1K0S171488, 1K0S172266, 4K0S192736, 3K0S185730, 3K0S185732, 3K0S185734, 3K0S185740, 3K0S186955, 3K0S187000, 4K0S190509, 4K0S190514, 4K0S190515, 4K0S190519, 4K0S190525, 4K0S190537, 4K0S191511, 4K0S191571, 4K0S191578, 4K0S192514, 4K0S192520, 4K0S192522, 4K0S192523, 4K0S192528, 4K0S192538, 4K0S192235, 4K0S192231, 4K0S192236, 4K0S192237, 2K0S180521, 2K0S180522, 2K0S180527, 3K0S186036, 3K0S182626, 3K0S182627, 3K0S182637, 3K0S182646, 3K0S184910, 3K0S185719, 3K0S185721, 3K0S185739, 3K0S185742, 3K0S186938, 3K0S186951, 3K0S186953, 3K0S186960, 3K0S186995, 3K0S186997, 4K0S190280, 4K0S191586, 4K0S191229, 4K0S191230, 4K0S191232, 4K0S191569, 4K0S191579, 4K0S191580, 4K0S192727, 4K0S192731, 2K0S179494, 2K0S179487, 3K0S182636, 4K0S192226, 4K0S192227, 4K0S192234, 4K0S192239, 4K0S192241, 4K0S192245, 3K0S186032, 3K0S184877, 3K0S184878, 3K0S184895, 3K0S185724, 3K0S185736, 3K0S186042, 3K0S186935, 3K0S186990, 4K0S190518, 4K0S190524, 4K0S191584, 4K0S192242, 4K0S192737, 3K0S182658, 4K0S191129, 4K0S191133, 4K0S192537, 4K0S192230, 2K0S180524, 2K0S180526, 3K0S185720, 2K0S180530, 2K0S180542, 4K0S190538, 4K0S191124, 3K0S184906, 4K0S191233, 3K0S185978, 3K0S186944, 2K0S181716, 3K0S182642, 3K0S185975, 2K0S180516, 3K0S186993, 2K0S179479, 2K0S180529, 2K0S180533, 2K0S179490, 3K0S182656, 3K0S184887, 3K0S182645, 3K0S182655, 2K0S179482, 2K0S179477, 3K0S182635, 3K0S185997, 3K0S186948, 3K0S184893, 4K0S191234, 1K0S172200, 2K0S179485, 1K0S171809, 4K0S191582, 1K0S171481, 3K0S182650, 3K0S186992, 3K0S182654, 3K0S185981, 3K0S186044, 1K0S172057, 4K0S191512, 3K0S185729, 3K0S185979, 3K0S182641, 3K0S182643, 3K0S184890, 4K0S192526, 4K0S192533, 4K0S192729, 4K0S192735, 1K0S171848, 1K0S172052, 3K0S185735, 3K0S184884, 3K0S184892, 1K0S171482, 4K0S191136, 4K0S191122, 4K0S191125, 4K0S191134, 4K0S191123, 4K0S191141, 4K0S192243, 4K0S192244, 4K0S192540, 4K0S190531, 3K0S184891, 3K0S185723, 3K0S185745, 3K0S185988, 3K0S186956, 3K0S187002, 1K0S171808, 4K0S190513, 3K0S185718, 4K0S190511, 4K0S190530, 3K0S182625, 2K0S181709, 2K0S181711, 3K0S186034, 3K0S186998, 3K0S186942, 1K0S172061, 1K0S171825, 1K0S171841, 1K0S171483, 1K0S171815, 2K0S179500, 2K0S181717, 3K0S186950, 3K0S185998, 3K0S184899, 4K0S192730, 4K0S190533, 3K0S185741, 3K0S186962, 4K0S190516, 3K0S185737, 3K0S185728, 4K0S192240, 4K0S192233, 3K0S185310, 2K0S180512, 2K0S180543, 4K0S190846, 3K0S185743, 1K0S172045, 3K0S184879, 3K0S184881, 3K0S184905, 3K0S186933, 2K0S179499, 2K0S179501, 2K0S181719, 3K0S187001, 3K0S186947, 3K0S185994, 3K0S185983, 1K0S172189, 3K0S184907, 3K0S185311, 3K0S184868, 3K0S186989, 3K0S186941, 4K0S192517, 1K0S171818, 4K0S191581, 1K0S171477, 1K0S171498, 2K0S181705, 4K0S192228, 1K0S171839, 1K0S171843, 3K0S186039, 4K0S191139, 4K0S191588, 1K0S171822, 1K0S171829, 2K0S181715, 3K0S182633, 3K0S182638, 3K0S186037, 4K0S190520, 2K0S180525, 2K0S180518, 3K0S185974, 1K0S171479, 3K0S184902, 1K0S171494, 3K0S184865, 3K0S184867, 3K0S184875, 3K0S184889, 3K0S185977, 3K0S185987, 3K0S185996, 3K0S182648, 2K0S181706, 1K0S172042, 3K0S185726, 3K0S186958, 4K0S192536, 3K0S185716, 4K0S192512, 4K0S192728, 1K0S171838, 2K0S181710, 3K0S185992, 4K0S190527, 4K0S190541, 2K0S180546, 3K0S186954, 3K0S182647, 3K0S184874, 3K0S185283, 4K0S190532, 4K0S190534, 3K0S182659, 1K0S171811, 1K0S171832, 1K0S171844, 3K0S186996, 3K0S186999, 3K0S185725, 3K0S185727, 3K0S185982, 4K0S190844, 4K0S190526, 4K0S191570, 1K0S171492, 3K0S186952, 1K0S171491, 3K0S182634, 2K0S181708, 3K0S186991, 3K0S186040, 3K0S185717, 1K0S172192, 2K0S179495, 3K0S182644, 4K0S190539, 4K0S190845, 4K0S190847, 4K0S192527, 1K0S172049, 3K0S182632, 3K0S182651, 3K0S186041, 2K0S179496, 3K0S186939, 4K0S192734, 3K0S185995, 4K0S191140, 3K0S184911, 1K0S172182, 4K0S191131, 4K0S191135, 2K0S181713, 4K0S191130, 3K0S184908, 4K0S192229, 4K0S190522, 1K0S172185, 4K0S192530, 2K0S180517, 2K0S180531, 4K0S190852, 4K0S190853, 2K0S179488, 4K0S191231, 3K0S184894, 2K0S179484, 3K0S182652, 3K0S182657, 4K0S192516, 4K0S190543, 1K0S172059, 1K0S172190, 3K0S184872, 3K0S182629, 3K0S185985, 3K0S186946, 4K0S190512, 1K0S172186, 1K0S172188, 1K0S171810, 1K0S171831, 1K0S171828, 1K0S171842, 3K0S185284, 3K0S185309, 3K0S185722, 3K0S184903, 4K0S190850, 3K0S185281, 3K0S186043, 3K0S184864, 1K0S171480, 3K0S182649, 3K0S185984, 4K0S190521, 4K0S190528, 4K0S190535, 4K0S190536, 4K0S190542, 4K0S192519, 4K0S192525, 4K0S192531, 1K0S172043, 1K0S172193, 2K0S179478, 2K0S179481, 4K0S191585, 4K0S192238, 4K0S192515, 4K0S192524, 3K0S182628, 2K0S179497, 3K0S182630, 3K0S186934, 1K0S171485, 3K0S185733, 3K0S186035, 4K0S192732, 3K0S185731, 1K0S171476, 1K0S172051, 3K0S182653, 3K0S182639, 4K0S192724, 4K0S192726, 1K0S171814, 4K0S190523, 4K0S190854, 4K0S190510, 4K0S191126, 4K0S191127, 1K0S171497, 3K0S182631, 1K0S171827, 3K0S184909, 1K0S171824, 1K0S171826, 1K0S171475, 1K0S171499, 2K0S179480, 2K0S179483, 2K0S180513, 2K0S180519, 3K0S186945, 3K0S186957, 3K0S186936, 3K0S186045, 2K0S181707, 2K0S181712, 2K0S181718, 1K0S171487, 3K0S186940, 3K0S186959, 3K0S185986, 3K0S185991, 4K0S190540, 2K0S180520, 2K0S180532, 2K0S180628, 4K0S190851, 4K0S191587, 3K0S185282, 3K0S186031, 2K0S181714, 3K0S184869, 3K0S184871, 3K0S184873, 3K0S184880, 3K0S184900, 3K0S184904, 3K0S184912, 3K0S184866, 3K0S184876, 3K0S184886, 3K0S184888, 3K0S184896, 3K0S184897, 3K0S184898, 3K0S185993, 3K0S186033, 4K0S192513, 4K0S192535, 4K0S191572, 4K0S190529, 1K0S171833, 1K0S171840, 3K0S185308, 1K0S171849, 1K0S172044, 4K0S192725, 4K0S192529, 2K0S180523, 4K0S191137, 3K0S186937, 3K0S186943, 3K0S186994, 1K0S172196, 1K0S172264, 1K0S172265, 1K0S172183, 1K0S172263, 1K0S171837, 1K0S171493, 1K0S172191, 1K0S172201, 1K0S171489, 1K0S171807, 1K0S172054, 1K0S172194, 1K0S172198, 1K0S171820, 1K0S172205, 1K0S171819, 1K0S171830, 1K0S171486, 1K0S171836, 2K0S179486, 2K0S179492, 2K0S179493, 2K0S179498, 1K0S171812, 1K0S171813, 1K0S171821, 1K0S172048, 1K0S172053, 1K0S172060, 1K0S172179, 1K0S172184, 1K0S172204, 1K0S171847, 1K0S172180, 1K0S172203, 1K0S172195, 1K0S172197, 1K0S171816, 1K0S171835, 1K0S172058, 1K0S172187, 1K0S172199, 3K0S184882, 3K0S184901, 3K0S184883, 3K0S185307, 3K0S185976, 4K0S191138, 4K0S190848, 4K0S191128, 4K0S192521, 3K0S182640, 1K0S171817, 3K0S185980, 3K0S186961, 3K0S186949, 4K0S191513, 1K0S171834, 2K0S179491, 4K0S192733, 4K0S192723.	531 units
Z-2342-2024	191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: 191014; UDI/DI: N/A (Canada only); Serial Number: 6K0S162351, 6K0S162352, 6K0S162353, 6K0S162354, 6K0S162355, 6K0S169113, 6K0S169114, 6K0S169115, 6K0S169116, 6K0S169117, 6K0S169118, 6K0S169119, 6K0S169120, 6K0S169121, 6K0S169122, 6K0S169123, 6K0S169124, 6K0S169125, 6K0S169126, 6K0S169127.	20 units (all OUS)
Z-2343-2024	190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: 190395; UDI/DI: 00840861100958; Serial Number: 6K0S-985P, 7K0S107747, 6K0S-021M, 7K0S103530, 6K0S-780R, 6K0S-192E, 6K0S-217E, 7K0S102986, 7K0S110138, 7K0S110142, 7K0S106422, 4K0S-P981, 4K0S-N154, 4K0S-N157, 4K0S-Q697, 5K0S-V190, 5K0S-V199, 6K0S-012R, 4K0S-M705, 4K0S-M708, 4K0S-N842, 4K0S-N843, 4K0S-N846, 4K0S-N850, 4K0S-N913, 4K0S-P289, 4K0S-P290, 4K0S-P298, 4K0S-P299, 4K0S-R079, 4K0S-R106, 4K0S-R114, 4K0S-R082, 4K0S-R136, 4K0S-S707, 4K0S-S708, 4K0S-S716, 6K0S-320H, 6K0S-325H, 6K0S-332H, 4K0S-S713, 5K0S-309C, 4K0S-M703, 4K0S-N847, 4K0S-R080, 4K0S-L722, 4K0S-N152, 4K0S-N155, 4K0S-N159, 4K0S-P291, 4K0S-P294, 4K0S-P295, 4K0S-Q694, 4K0S-Q688, 4K0S-R107, 4K0S-R081, 5K0S-T891, 4K0S-R135, 7K0S106375, 5K0S-168D, 5K0S-Z661, 5K0S-Z668, 4K0S-S711, 5K0S-306C, 5K0S-159D, 5K0S-881D, 6K0S-491J, 6K0S-501F, 6K0S-435N, 7K0S108256, 6K0S-746N, 5K0S-311C, 6K0S-508F, 6K0S-016M, 5K0S-305C, 6K0S-532F, 6K0S-318H, 6K0S-722R, 5K0S-Y002, 6K0S-481K, 6K0S-488K, 6K0S-669L, 4K0S-Q643, 5K0S-Y003, 4K0S-M704, 4K0S-M707, 4K0S-N849, 4K0S-P288, 4K0S-Q641, 4K0S-Q689, 4K0S-Q690, 4K0S-Q691, 4K0S-R109, 4K0S-R113, 4K0S-R134, 4K0S-R137, 4K0S-S704, 5K0S-T897, 5K0S-T898, 5K0S-V200, 5K0S-V201, 5K0S-X989, 5K0S-883D, 6K0S-468G, 6K0S-847G, 6K0S-848G, 6K0S-092L, 6K0S-322L, 6K0S-673L, 6K0S-992P, 6K0S-998P, 4K0S-M706, 4K0S-R083, 4K0S-S712, 4K0S-S722, 5K0S-V191, 5K0S-V204, 5K0S-X987, 5K0S-X990, 5K0S-Z667, 5K0S-466B, 6K0S-219E, 6K0S-482J, 6K0S-835N, 6K0S-778R, 7K0S100621, 7K0S102665, 7K0S103781, 4K0S-S715, 5K0S-V202, 5K0S-885D, 4K0S-N844, 4K0S-P292, 4K0S-S706, 5K0S-T887, 5K0S-T892, 5K0S-Z664, 5K0S-184C, 5K0S-Z654, 5K0S-Z660, 6K0S-437N, 6K0S-834N, 6K0S-015R, 5K0S-160D, 6K0S-815K, 6K0S-022M, 6K0S-757N, 6K0S-504F, 7K0S100578, 6K0S-482K, 6K0S-485K, 6K0S-981P, 6K0S-007Q, 6K0S-805K, 6K0S-777R, 7K0S102982, 7K0S100940, 5K0S-Z666, 6K0S-484J, 6K0S-325L, 6K0S-486J, 6K0S-010M, 7K0S100714, 6K0S-006M, 6K0S-060N, 6K0S-432N, 6K0S-787R, 6K0S-952Q, 7K0S100579, 7K0S107999, 6K0S-017R, 7K0S102656, 6K0S-750N, 5K0S-882D, 6K0S-008M, 6K0S-026M, 6K0S-945Q, 6K0S-010R, 6K0S-671L, 6K0S-018M, 5K0S-880D, 6K0S-216E, 6K0S-503F, 6K0S-438N, 7K0S109372, 6K0S-220E, 6K0S-515F, 6K0S-510F, 6K0S-507F, 6K0S-484G, 6K0S-331H, 6K0S-326H, 6K0S-323H, 6K0S-483J, 6K0S-820K, 6K0S-610L, 6K0S-756N, 7K0S105078, 5K0S-879D, 6K0S-471G, 6K0S-477G, 6K0S-845G, 6K0S-672L, 6K0S-511F, 6K0S-336H, 6K0S-322H, 6K0S-431N, 6K0S-051M, 7K0S100618, 6K0S-478K, 6K0S-050M, 6K0S-976P, 6K0S-807K, 6K0S-024M, 7K0S101630, 7K0S106399, 7K0S107631, 7K0S107628, 7K0S108079, 7K0S108483, 7K0S110137, 7K0S106378, 7K0S109370, 5K0S-Z658, 4K0S-S720, 4K0S-S710, 4K0S-P296, 6K0S-816K, 7K0S103840, 7K0S103896, 7K0S107752, 7K0S107922, 7K0S103596, 7K0S108258, 6K0S-334H, 6K0S-338H, 6K0S-339H, 6K0S-479G, 6K0S-846G, 6K0S-851G, 6K0S-852G, 6K0S-982G, 5K0S-V196, 5K0S-463B, 7K0S110484, 6K0S-025M, 7K0S110416, 7K0S110417, 7K0S110418, 7K0S107748, 5K0S-Y007, 5K0S-Z663, 5K0S-Z656, 5K0S-X986, 5K0S-164D, 6K0S-718R, 6K0S-776R, 6K0S-715R, 6K0S-717R, 6K0S-727R, 6K0S-729R, 6K0S-732R, 6K0S-783R, 7K0S103782, 7K0S108482, 6K0S-808K, 7K0S102985, 7K0S108257, 7K0S105021, 7K0S101634, 6K0S-014Q, 5K0S-T888, 5K0S-T889, 5K0S-163D, 5K0S-167D, 6K0S-993P, 7K0S110119, 7K0S110136, 5K0S-354D, 6K0S-027M, 6K0S-056N, 6K0S-057N, 7K0S108373, 7K0S103897, 5K0S-321C, 4K0S-N160, 6K0S-319H, 5K0S-451B, 7K0S103050, 7K0S109903, 7K0S109904, 7K0S110431, 6K0S-490K, 7K0S100577, 7K0S100716, 7K0S105993, 7K0S108486, 5K0S-Z659, 6K0S-472J, 7K0S109397, 6K0S-317L, 6K0S-320L, 7K0S106053, 6K0S-491K, 7K0S106458, 7K0S107751, 4K0S-N158, 7K0S107630, 7K0S103843, 7K0S108328, 7K0S108376, 7K0S108485, 7K0S100718, 5K0S-T899, 5K0S-166D, 5K0S-355D, 7K0S106397, 7K0S108330, 5K0S-T881, 6K0S-017M, 7K0S106400, 7K0S106456, 7K0S106467, 4K0S-L720, 4K0S-L721, 6K0S-475K, 6K0S-477K, 6K0S-011M, 6K0S-023M, 6K0S-053M, 7K0S106460, 6K0S-472K, 7K0S103898, 7K0S103529, 7K0S109466, 4K0S-R110, 6K0S-512F, 6K0S-469J, 7K0S109462, 5K0S-V193, 6K0S-986P, 7K0S100936, 7K0S107745, 7K0S107996, 7K0S107997, 4K0S-S721, 4K0S-Q636, 6K0S-487J, 6K0S-975P, 6K0S-987P, 6K0S-997P, 6K0S-726R, 6K0S-781R, 7K0S104957, 7K0S105020, 7K0S107749, 7K0S107750, 6K0S-473J, 6K0S-774R, 7K0S108080, 4K0S-P982, 5K0S-V195, 5K0S-V197, 5K0S-454B, 5K0S-320C, 6K0S-324H, 6K0S-475J, 7K0S110486, 6K0S-994P, 7K0S109464, 5K0S-T894, 7K0S107924, 6K0S-019M, 6K0S-946Q, 6K0S-193E, 6K0S-822K, 7K0S106056, 7K0S108374, 6K0S-481J, 7K0S107995, 5K0S-Y009, 5K0S-Y010, 7K0S100615, 7K0S100616, 7K0S108010, 7K0S103597, 5K0S-T890, 5K0S-V198, 5K0S-Z650, 5K0S-457B, 6K0S-474G, 6K0S-478J, 6K0S-471J, 7K0S105075, 7K0S109374, 5K0S-866B, 6K0S-319L, 6K0S-471K, 5K0S-Y008, 5K0S-Y006, 5K0S-X982, 5K0S-Z651, 5K0S-Z662, 7K0S101632, 7K0S108372, 6K0S-509F, 6K0S-516F, 6K0S-770R, 6K0S-949Q, 6K0S-477J, 6K0S-817K, 6K0S-939Q, 6K0S-007M, 7K0S102604, 7K0S105994, 7K0S107753, 5K0S-310C, 7K0S103532, 6K0S-974P, 6K0S-728R, 6K0S-340H, 5K0S-867B, 6K0S-191E, 6K0S-218E, 6K0S-063N, 6K0S-748N, 6K0S-754N, 7K0S100937, 7K0S100938, 7K0S101631, 7K0S110422, 7K0S110434, 7K0S110460, 7K0S110517, 7K0S110718, 7K0S105016, 7K0S107746, 4K0S-Q692, 6K0S-029Q, 5K0S-307C, 5K0S-358D, 6K0S-337H, 6K0S-844G, 6K0S-814K, 6K0S-819K, 6K0S-059N, 6K0S-062N, 4K0S-P980, 7K0S104956, 7K0S105990, 7K0S106054, 4K0S-N156, 7K0S106459, 7K0S107629, 6K0S-951Q, 7K0S109398, 7K0S110456, 7K0S110706, 4K0S-N151, 4K0S-N153, 4K0S-J948, 4K0S-J950, 4K0S-J951, 5K0S-V192, 5K0S-V194, 6K0S-195E, 6K0S-751N, 7K0S102598, 7K0S109399, 7K0S102664, 6K0S-534F, 7K0S107627, 6K0S-753N, 7K0S109463, 6K0S-670L, 6K0S-004Q, 5K0S-Y005, 7K0S108375, 7K0S106376, 5K0S-468B, 6K0S-436N, 7K0S109371, 7K0S109400, 6K0S-470K, 6K0S-802K, 7K0S101633, 7K0S110428, 7K0S104959, 7K0S110118, 7K0S110120, 7K0S105991, 7K0S106115, 6K0S-009R, 6K0S-943Q, 6K0S-950Q, 6K0S-953Q, 6K0S-955Q, 6K0S-731R, 7K0S103047, 7K0S103528, 7K0S103783, 7K0S103899, 5K0S-T884, 4K0S-Q638, 4K0S-Q642, 5K0S-X983, 4K0S-Q639, 4K0S-R111, 7K0S106377, 7K0S110705, 7K0S109905, 7K0S104958, 7K0S103844, 7K0S107921, 7K0S109373, 7K0S110412, 4K0S-S705, 4K0S-S717, 7K0S107925, 7K0S102599, 7K0S102983, 6K0S-467G, 7K0S103841, 6K0S-019R, 7K0S106055, 7K0S106398, 6K0S-478G, 7K0S108012, 6K0S-473K, 6K0S-484K, 7K0S105022, 7K0S100576, 6K0S-028Q, 6K0S-812K, 6K0S-752N, 6K0S-010Q, 7K0S108329, 7K0S109906, 7K0S109465, 6K0S-506F, 6K0S-321H, 6K0S-327H, 6K0S-479K, 6K0S-486K, 6K0S-468K, 6K0S-806K, 6K0S-730R, 6K0S-773R, 4K0S-J949, 4K0S-J952, 4K0S-N845, 4K0S-N848, 4K0S-P293, 4K0S-P297, 4K0S-Q634, 4K0S-Q635, 4K0S-Q637, 4K0S-Q640, 4K0S-Q695, 4K0S-Q693, 4K0S-Q696, 4K0S-R108, 4K0S-R112, 4K0S-R115, 4K0S-S709, 4K0S-S718, 5K0S-T880, 5K0S-T882, 5K0S-T883, 5K0S-T885, 5K0S-T886, 5K0S-T893, 5K0S-T895, 5K0S-T896, 5K0S-453B, 5K0S-455B, 5K0S-456B, 5K0S-459B, 5K0S-461B, 5K0S-465B, 5K0S-467B, 5K0S-469B, 5K0S-470B, 5K0S-Z653, 5K0S-180C, 5K0S-181C, 5K0S-182C, 5K0S-183C, 5K0S-185C, 5K0S-460B, 5K0S-464B, 5K0S-868B, 5K0S-869B, 5K0S-Z657, 5K0S-356D, 5K0S-360D, 5K0S-361D, 5K0S-362D, 5K0S-363D, 5K0S-357D, 5K0S-359D, 5K0S-877D, 5K0S-884D, 5K0S-886D, 6K0S-470J, 6K0S-474J, 6K0S-479J, 6K0S-488J, 6K0S-490J, 6K0S-326L, 6K0S-469K, 6K0S-803K, 6K0S-811K, 6K0S-818K, 6K0S-085L, 6K0S-318L, 6K0S-321L, 6K0S-323L, 6K0S-327L, 6K0S-480K, 6K0S-487K, 6K0S-492K, 6K0S-810K, 6K0S-821K, 6K0S-011R, 6K0S-013R, 6K0S-014R, 6K0S-018R, 6K0S-938Q, 6K0S-940Q, 6K0S-941Q, 6K0S-942Q, 6K0S-944Q, 6K0S-958Q, 7K0S102601, 7K0S102657, 7K0S103048, 7K0S103531, 7K0S103595, 7K0S103598, 7K0S103599, 7K0S103780, 7K0S103842, 7K0S103895, 7K0S110141, 7K0S110461, 7K0S110513, 7K0S110518, 7K0S110521, 7K0S110540, 7K0S110715, 7K0S110733, 7K0S110739, 7K0S110769, 7K0S110462, 7K0S110514, 7K0S110542, 7K0S110543, 7K0S110710, 7K0S110711, 7K0S110713, 7K0S110735, 7K0S110737, 7K0S110750, 7K0S110489, 7K0S110492, 7K0S110732, 7K0S110743, 7K0S110770, 8K0S117578, 8K0S117579, 8K0S117580, 8K0S117581, 8K0S117582, 8K0S125841, 8K0S125842, 8K0S125844, 8K0S125845, 8K0S125846, 8K0S125847, 8K0S125848, 8K0S125849, 8K0S125850, 8K0S125865, 7K0S110487, 8K0S128089, 8K0S128090, 8K0S128091, 8K0S128092, 8K0S128093, 8K0S128094, 8K0S128095, 8K0S128096, 8K0S128097, 8K0S128098, 8K0S128099, 8K0S128100, 8K0S128101, 8K0S128102, 8K0S128103, 8K0S128104, 8K0S128105, 8K0S128106, 8K0S128107, 8K0S128108, 8K0S128109, 8K0S128110, 8K0S128111, 8K0S128112, 8K0S128113, 8K0S128114, 8K0S128115, 8K0S128116, 8K0S128117, 8K0S128118, 8K0S128119, 8K0S128120, 8K0S131366, 8K0S131367, 8K0S131368, 8K0S131371, 8K0S131373, 8K0S131374, 8K0S131375, 8K0S131376, 8K0S131377, 8K0S131378, 8K0S131381, 8K0S131382, 8K0S131383, 8K0S131385, 8K0S131386, 8K0S131387, 8K0S131389, 8K0S131391, 8K0S131392, 8K0S131393, 8K0S131395, 8K0S131398, 8K0S131401, 8K0S131402, 8K0S131403, 8K0S131405, 8K0S131415, 8K0S131416, 8K0S131421, 8K0S131422, 8K0S131424, 8K0S131428, 8K0S131432, 8K0S131437, 8K0S131445, 8K0S131369, 8K0S131370, 8K0S131372, 8K0S131379, 8K0S131380, 8K0S131384, 8K0S131388, 8K0S131390, 8K0S131394, 8K0S131396, 8K0S131397, 8K0S131399, 8K0S131400, 8K0S131404, 8K0S131412, 8K0S131413, 8K0S131414, 8K0S131420, 8K0S131423, 8K0S131425, 8K0S131427, 8K0S131429, 8K0S131430, 8K0S131431, 8K0S131433, 8K0S131434, 8K0S131435, 8K0S131436, 8K0S131438, 8K0S131439, 8K0S131440, 8K0S131441, 8K0S131442, 8K0S131443, 8K0S131444, 8K0S131446, 8K0S131447, 6K0S-668L, 6K0S-721R, 6K0S-775R, 6K0S-779R, 6K0S-782R, 6K0S-957Q, 7K0S102597, 7K0S102600, 7K0S102660, 7K0S102663, 7K0S108312, 7K0S108484, 5K0S-312C, 5K0S-Y004, 6K0S-020M, 6K0S-333H, 6K0S-481G, 6K0S-493J, 6K0S-772R, 7K0S100719, 7K0S102602, 7K0S108327, 6K0S-335H, 6K0S-485J, 6K0S-489J, 6K0S-517F, 6K0S-716R, 6K0S-771R, 6K0S-809K, 6K0S-849G, 7K0S102603, 7K0S102662, 0K0S151413, 5K0S-308C, 5K0S-T139, 5K0S-Y001, 6K0S-492J, 6K0S-745N, 7K0S100720, 9K0S134408, 9K0S134500, 1K0S167702, 1K0S167703, 1K0S167704, 1K0S167705, 1K0S167706, 1K0S167707, 1K0S167708, 1K0S167709, 1K0S167710, 1K0S167711, 1K0S167712, 1K0S167713, 1K0S167714, 1K0S167715, 1K0S167716, 1K0S167717, 1K0S167718, 1K0S167719, 1K0S167720, 1K0S167721, 1K0S169224, 1K0S169226, 1K0S169227, 1K0S169228, 1K0S169229, 1K0S169231, 1K0S169232, 1K0S169235, 1K0S169238, 1K0S169239, 1K0S169240, 1K0S169241, 1K0S169242, 1K0S169243, 1K0S169244, 1K0S169225, 1K0S169230, 1K0S169233, 1K0S169234, 1K0S169236, 1K0S169237, 1K0S170300, 1K0S170301, 1K0S170302, 1K0S170303, 1K0S170304, 1K0S170305, 1K0S170306, 1K0S170309, 1K0S170310, 1K0S170311, 2K0S174112, 2K0S174113, 2K0S174114, 2K0S174115, 2K0S174116, 2K0S174117, 2K0S174118, 2K0S174119, 2K0S174120, 2K0S174121, 2K0S174122, 2K0S174123, 2K0S174124, 2K0S174125, 2K0S174126, 2K0S174127, 2K0S174128, 2K0S174129, 2K0S174131, 2K0S174132, 2K0S174133, 2K0S174134, 2K0S174136, 2K0S174137, 2K0S174138, 2K0S174139, 2K0S174140, 2K0S174141, 2K0S174142, 2K0S174144, 2K0S174145, 2K0S174146, 2K0S174147, 2K0S174148, 2K0S174149, 2K0S174229, 2K0S174230, 2K0S174232, 2K0S174234, 2K0S174235, 2K0S174236, 2K0S174237, 2K0S174238, 2K0S174239, 2K0S174240, 2K0S174241, 2K0S174244, 2K0S174245, 2K0S174246, 2K0S174130, 2K0S174135, 2K0S174228, 2K0S174231, 2K0S174233, 2K0S174242, 2K0S174243, 2K0S175602, 2K0S175603, 2K0S175605, 2K0S175606, 2K0S175607, 2K0S175608, 2K0S175609, 2K0S175610, 2K0S175611, 2K0S175612, 2K0S175613, 2K0S175614, 2K0S175615, 2K0S175616, 2K0S177609, 2K0S177610, 2K0S177611, 2K0S177612, 2K0S177613, 2K0S177614, 2K0S177615, 2K0S177616, 2K0S177617, 2K0S177618, 2K0S177619, 2K0S177620, 2K0S177621, 2K0S177622, 2K0S177623, 2K0S177624, 2K0S177625, 2K0S177626, 2K0S177627, 2K0S177628, 2K0S181311, 2K0S181312, 2K0S181313, 2K0S181314, 2K0S181317, 2K0S181318, 2K0S181320, 2K0S181321, 2K0S181322, 2K0S181323, 2K0S181324, 2K0S181325, 2K0S181326, 2K0S181328, 2K0S181329, 2K0S181331, 2K0S181332, 2K0S181339, 2K0S181344, 2K0S181346, 2K0S181315, 2K0S181316, 2K0S181319, 2K0S181327, 2K0S181330, 2K0S181338, 2K0S181340, 2K0S181343, 2K0S181345, 2K0S181347, 3K0S183305, 3K0S183306, 3K0S183307, 3K0S183308, 3K0S183309, 3K0S183310, 3K0S183311, 3K0S183312, 3K0S183313, 3K0S183314, 3K0S183315, 3K0S183316, 3K0S183317, 3K0S183318, 3K0S183319, 3K0S183320, 3K0S183321, 3K0S183322, 3K0S183323, 3K0S183324, 3K0S183906, 3K0S183907, 3K0S183908, 3K0S183909, 3K0S183910, 3K0S183911, 3K0S183912, 3K0S183913, 3K0S183914, 3K0S183915, 3K0S183916, 3K0S183917, 3K0S183918, 3K0S183919, 3K0S183920, 3K0S183971, 3K0S183972, 3K0S183973, 3K0S183974, 3K0S183975, 3K0S183976, 3K0S183977, 3K0S183978, 3K0S183979, 3K0S183980, 3K0S184849, 3K0S184850, 3K0S184851, 3K0S184852, 3K0S184853, 3K0S184854, 3K0S184855, 3K0S184856, 3K0S184857, 3K0S184858, 3K0S184859, 3K0S184860, 3K0S184861, 3K0S184862, 3K0S184863, 2K0S174143, 2K0S175604, 4K0S190837, 4K0S190838, 4K0S190842, 4K0S190843, 4K0S190829, 4K0S190830, 4K0S190831, 4K0S190832, 4K0S190833, 4K0S190834, 4K0S190835, 4K0S190836, 4K0S190839, 4K0S190840, 4K0S190841, 5K0S192866, 5K0S192867, 5K0S192868, 5K0S192869, 5K0S192907, 5K0S192985, 5K0S-Z665, 6K0S-483K, 6K0S-801K, 6K0S-813K, 7K0S100575, 6K0S-996P, 7K0S102605, 6K0S-469G, 4K0S-J232, 4K0S-J943, 5K0S-878D, 6K0S-502F, 6K0S-533F, 6K0S-466G, 6K0S-470G, 6K0S-473G, 6K0S-476G, 6K0S-482G, 6K0S-483G, 6K0S-485G, 6K0S-013Q, 5K0S-162D, 5K0S-165D, 5K0S-161D, 6K0S-480G, 6K0S-061N, 7K0S107754, 7K0S107923, 7K0S110433, 5K0S-X988, 6K0S-006Q, 6K0S-008Q, 6K0S-008R, 6K0S-009Q, 6K0S-011Q, 6K0S-012Q, 6K0S-027Q, 6K0S-030Q, 6K0S-031Q, 6K0S-954Q, 7K0S108015, 7K0S108255, 7K0S109401, 7K0S109902, 7K0S110123, 7K0S110121, 5K0S-X981, 6K0S-194E, 7K0S105992, 4K0S-S714, 7K0S107994, 4K0S-L723, 4K0S-S703, 4K0S-S719, 4K0S-J944, 4K0S-J947, 7K0S103049, 7K0S102661, 6K0S-747N, 6K0S-749N, 6K0S-755N, 6K0S-758N, 7K0S104960, 7K0S105023, 7K0S105076, 7K0S105077, 7K0S105080, 7K0S100617, 7K0S102659, 7K0S102984, 7K0S103051, 7K0S106374.	1,156 units
Z-2344-2024	RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: RTL190395 (Rental Units); UDI/DI: 00840861100958; Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L,	17 Units
Z-2345-2024	RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: RTL190828 (Rental Units); UDI/DI: 00840861100941; Serial Number: 1K0S172181	1 unit
Z-2346-2024	RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: RTL190904 (Rental Units); UDI/DI: 00840861100965; Serial Numbers: 5K0S193320, 5K0S194164.	2 units
Z-2347-2024	RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A; Model Number: RTLR190395 (Refurbished Rental units); UDI/DI: 00840861100958; Serial Numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, 5K0S-U131.	6 units

Based on the official FDA remedy

What to do — step by step

Check Spare Part Model
Verify the model number on your spare part is F40015481 Rev A.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Domestic: Nationwide Distribution. International: Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 44 days after the firm started it.

Jun 3, 2024Firm started the recall
Jul 11, 2024FDA classified it Class II
Jul 17, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Fresenius Medical recalls

Latest medical device recalls

Keep exploring

More Fresenius Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/54931-fresenius-medical-2008k-home-blood-pump-rotor-spare-part-recall">Fresenius Medical: 2008K@HOME Blood Pump Rotor Spare Part Recall - Loose Guide Sheaves (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2344-2024 (June 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2344-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.