CLASS II ONGOING Device recall · Reported 29 May 2024 · FDA Enforcement Report

2008T BlueStar Hemodialysis Machine recalled by Fresenius Medical Care

Fresenius Medical Care Holdings is recalling 2008T BlueStar Hemodialysis Machine, distributed nationwide in the US. The recall was initiated on 17 Apr 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesComponent: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909,

Quantity recalled334 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1869-2024
FDA event ID: 94463
Recalling firm: Fresenius Medical Care Holdings, Waltham, MA
Classification: Class II
Status: Ongoing
Recall initiated: 17 Apr 2024
FDA classified: 17 May 2024
Reported: 29 May 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Apr 2024	Recall initiated by company
17 May 2024	Classified by FDA	+30 days
29 May 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Product as listed by the FDA

2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191128, UDI/DI: 00840861102105; Serial Numbers: 3T0S274210, 1T0S260183, 1T0S260455, 1T0S260456, 1T0S260485, 1T0S260273, 1T0S260283, 1T0S260490, 1T0S260158, 1T0S260182, 1T0S260266, 3T0S269011, 3T0S273223, 3T0S274216, 3T0S274225, 3T0S274678, 3T0S274680, 1T0S260281, 2T0S268008, 2T0S268016, 2T0S264775, 2T0S268009, 2T0S268013, 2T0S268014, 2T0S268015, 3T0S269021, 3T0S269026, 3T0S274215, 3T0S274222, 3T0S274231, 3T0S274234, 1T0S260154, 1T0S260481, 1T0S260543, 1T0S260550, 1T0S260552, 3T0S274213, 3T0S274230, 1T0S260242, 1T0S260250, 1T0S260510, 1T0S260514, 2T0S267901, 2T0S267905, 2T0S267906, 2T0S267911, 1T0S260541, 1T0S260546, 2T0S264780, 3T0S274233, 3T0S274685, 3T0S274691, 3T0S274697, 1T0S260159, 1T0S260164, 1T0S260172, 1T0S260212, 1T0S260216, 1T0S260221, 1T0S260269, 1T0S260270, 1T0S260276, 1T0S260292, 1T0S260295, 1T0S260528, 3T0S273221, 3T0S274217, 3T0S274218, 3T0S274219, 3T0S274220, 3T0S274223, 3T0S274226, 3T0S274227, 3T0S274228, 3T0S274232, 3T0S274682, 3T0S274684, 3T0S274690, 3T0S274692, 3T0S274693, 3T0S274698, 1T0S260150, 1T0S260174, 1T0S260192, 1T0S260554, 1T0S260534, 3T0S274214, 3T0S274688, 1T0S260286, 2T0S264786, 3T0S274679, 3T0S274681, 3T0S274683, 3T0S274686, 3T0S274694, 3T0S274695, 3T0S274699, 3T0S274700, 1T0S260544, 1T0S260268, 1T0S260294, 3T0S269020, 3T0S269030, 3T0S269031, 1T0S260227, 2T0S267900, 2T0S267904, 1T0S260284, 1T0S260457, 1T0S260548, 3T0S269013, 3T0S269015, 3T0S269028, 3T0S271557, 3T0S271562, 3T0S271563, 3T0S271570, 3T0S271571, 3T0S271573, 3T0S271574, 3T0S271575, 3T0S271576, 3T0S269033, 3T0S269035, 3T0S271561, 3T0S271566, 3T0S271568, 3T0S273244, 1T0S260493, 1T0S260501, 1T0S260506, 1T0S260515, 1T0S260526, 1T0S260279, 1T0S260155, 1T0S260156, 1T0S260166, 1T0S260167, 1T0S260185, 1T0S260188, 1T0S260200, 3T0S269014, 3T0S269016, 3T0S269022, 2T0S264805, 2T0S264776, 2T0S264778, 2T0S264794, 2T0S264818, 2T0S264822, 2T0S264787, 2T0S264792, 3T0S269017, 3T0S269018, 3T0S269019, 3T0S271558, 3T0S271560, 3T0S271564, 3T0S271565, 3T0S271572, 1T0S256406, 2T0S267910, 3T0S273219, 3T0S273232, 3T0S274221, 1T0S260151, 1T0S260178, 1T0S260152, 1T0S260278, 1T0S260288, 1T0S260488, 1T0S260533, 1T0S260249, 1T0S260259, 1T0S260262, 1T0S260198, 1T0S260291, 2T0S268012, 1T0S260173, 3T0S274211, 3T0S274224, 2T0S268011, 3T0S273220, 3T0S273222, 3T0S273224, 3T0S273225, 3T0S273226, 3T0S273227, 3T0S273228, 3T0S273229, 3T0S273230, 3T0S273233, 3T0S273234, 3T0S273235, 3T0S273236, 3T0S273237, 3T0S273238, 3T0S273239, 3T0S273240, 3T0S273241, 3T0S273242, 3T0S273243, 1T0S260267, 1T0S260275, 3T0S269012, 3T0S269023, 3T0S269024, 3T0S269025, 3T0S269027, 3T0S269029, 3T0S269032, 3T0S269034, 1T0S260204, 1T0S260460, 1T0S260482, 1T0S260513, 1T0S260516, 1T0S260527, 1T0S260540, 1T0S260545, 2T0S267903, 2T0S264781, 3T0S271559, 3T0S271567, 3T0S271569, 1T0S260290, 1T0S260175, 1T0S260282, 1T0S260508, 1T0S260566, 1T0S260285, 2T0S264783, 2T0S264814, 1T0S260157, 1T0S260161, 1T0S260162, 1T0S260163, 1T0S260165, 1T0S260169, 1T0S260176, 1T0S260177, 1T0S260179, 1T0S260187, 1T0S260189, 1T0S260191, 1T0S260193, 1T0S260195, 1T0S260196, 1T0S260197, 1T0S260199, 1T0S260201, 1T0S260202, 1T0S260203, 1T0S260207, 1T0S260208, 1T0S260209, 1T0S260210, 1T0S260211, 1T0S260213, 1T0S260214, 1T0S260215, 1T0S260217, 1T0S260218, 1T0S260219, 1T0S260220, 1T0S260222, 1T0S260223, 1T0S260224, 1T0S260225, 1T0S260228, 1T0S260229, 1T0S260230, 1T0S260231, 1T0S260232, 1T0S260233, 1T0S260235, 1T0S260236, 1T0S260237, 1T0S260239, 1T0S260243, 1T0S260245, 1T0S260247, 1T0S260251, 1T0S260253, 1T0S260255, 1T0S260256, 1T0S260257, 1T0S260258, 1T0S260260, 1T0S260272, 1T0S260453, 1T0S260458, 1T0S260459, 1T0S260483, 1T0S260500, 1T0S260502, 1T0S260507, 1T0S260519, 1T0S260523, 1T0S260531, 1T0S260542, 1T0S260549, 1T0S260553, 1T0S260565, 2T0S264774, 2T0S264777, 2T0S264779, 2T0S264782, 2T0S264784, 2T0S264788, 2T0S264791, 2T0S264793, 2T0S264796, 2T0S264797, 2T0S264800, 2T0S264801, 2T0S264803, 2T0S264804, 2T0S264807, 2T0S264811, 2T0S264819, 2T0S264821, 2T0S268010, 1T0S260194, 1T0S260238, 1T0S260293, 1T0S260461, 2T0S264802, 3T0S274212, 2T0S267899, 2T0S267902, 2T0S267907, 2T0S267908, 2T0S267909,

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 94463

This product is part of a recall event; the main page for the event is Blood Pump Rotor recalled by Fresenius Medical Care.

Reported	Class	Recall	Company	Reason	Where
29 May 2024	CLASS II	Blood Pump Rotor recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
29 May 2024	CLASS II	2008T BlueStar Hemodialysis Machine recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide

More recalls from Fresenius Medical Care Holdings

All 165

Reported	Class	Recall	Company	Reason	Where
15 Jul 2026Device	CLASS II	5008X Blood Tubing Set recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	Nationwide
17 Jun 2026Device	CLASS II	Bicarby" Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Packaging Defects	Nationwide
17 Jun 2026Device	CLASS II	Bicarby Dialysate recalled by Fresenius Medical Care	Fresenius Medical Care Holdings	Other	TX
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide
13 May 2026Drug	CLASS II	Delflex, Dextrose Peritoneal Dialysis Solution recalled	Fresenius Medical Care Holdings	Sterility	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide