--- title: "2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump ... — FDA record Z-1868-2024 | Is It on Recall" description: "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 sh" url: https://isitonrecall.com/recall/fda-device-z-1868-2024-2008t-bluestar-hemodialysis-machine-model-191126-with-component-blood-pump-rotor-model-number-f40015/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. — FDA record Z-1868-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Apr 17, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A. - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Fresenius Medical Care Holdings, Inc. - **Quantity**: 12,292 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1868-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1868-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | Component: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots. Finished Devices: Model Number: 191126, UDI/DI: 00840861102099; Serial Numbers: 3T0S270687, 3T0S270700, 3T0S274007, 3T0S274009, 3T0S274011, 3T0S274012, 3T0S274016, 3T0S274057, 3T0S274859, 3T0S274920, 3T0S274922, 3T0S274923, 3T0S274938, 3T0S274957, 3T0S274969, 3T0S274970, 3T0S274980, 3T0S274985, 3T0S274996, 3T0S274997, 3T0S275004, 3T0S275009, 3T0S275011, 1T0S262226, 1T0S262249, 1T0S262254, 1T0S262257, 1T0S262265, 1T0S262266, 1T0S262267, 1T0S262268, 1T0S262269, 1T0S262272, 1T0S262273, 1T0S262274, 1T0S262275, 1T0S262276, 1T0S262278, 1T0S262279, 1T0S262280, 1T0S262282, 1T0S262283, 1T0S262284, 1T0S262285, 1T0S262286, 1T0S262289, 1T0S262293, 1T0S262294, 1T0S262296, 1T0S262297, 1T0S262299, 1T0S262300, 1T0S262305, 1T0S262313, 1T0S262315, 1T0S262319, 1T0S262321, 4T0S275623, 4T0S275627, 4T0S275628, 4T0S275629, 4T0S275639, 4T0S275649, 4T0S275654, 4T0S275662, 4T0S275664, 4T0S275666, 4T0S275677, 4T0S275682, 4T0S275685, 4T0S275688, 4T0S275692, 4T0S275703, 4T0S275729, 4T0S275738, 4T0S275742, 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4T0S276937, 4T0S276938, 4T0S276942, 4T0S276953, 4T0S276958, 4T0S276959, 4T0S276971, 4T0S276974, 4T0S276975, 4T0S276977, 4T0S276982, 4T0S276984, 4T0S276987, 4T0S276989, 4T0S276993, 4T0S276994, 4T0S276995, 4T0S276996, 4T0S276997, 4T0S277001, 4T0S277006, 4T0S277016, 4T0S277036, 0T0S255674, 1T0S255712, 1T0S255721, 1T0S255722, 1T0S255723, 1T0S255729, 1T0S255730, 1T0S255731, 1T0S255732, 1T0S255748, 1T0S255787, 1T0S255799, 1T0S255802, 1T0S255804, 1T0S258762, 1T0S258794, 1T0S258796, 1T0S258801, 4T0S277102, 4T0S277343, 4T0S277393, 4T0S277397, 4T0S277399, 4T0S277422, 4T0S277429, 4T0S277435, 4T0S277445, 4T0S277446, 4T0S277451, 4T0S277458, 4T0S277461, 4T0S277465, 4T0S277481, 4T0S277483, 4T0S277485, 4T0S277489, 4T0S276375, 4T0S276492, 4T0S276534, 4T0S276543, 4T0S276553, 4T0S276601, 4T0S276602, 4T0S276604, 4T0S276605, 4T0S276612, 4T0S276618, 4T0S276627, 4T0S276647, 4T0S276650, 4T0S276652, 4T0S276660, 4T0S276664, 0T0S255132, 3T0S274823, 3T0S274824, 3T0S274825, 3T0S274827, 3T... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1868-2024%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide distribution. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: May 29, 2024 - **Recall initiation date**: Apr 17, 2024 - **Center classification date**: May 17, 2024 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1868-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fresenius Medical Care Holdings, Inc. records](https://isitonrecall.com/brand/fresenius-medical-care-holdings-inc/)