Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component
Fresenius recalls 931 BlueStar hemodialysis machines due to loose guide sheaves in blood pump rotors. Facilities should immediately discontinue use of affected units.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical medical device component. While no illnesses or injuries have been reported, loose or dislodged sheaves in a blood pump rotor represent a risk of harm to patients dependent on hemodialysis treatment.
Plain-English summary
Fresenius Medical Care is recalling 931 BlueStar hemodialysis machines (Model 191124) with affected blood pump rotor components (Part Number F40015481 Rev A). An increased number of complaints have been reported regarding loose or dislodged guide sheaves in the blood pump rotor after the machines have been in use.
The recalled units were distributed nationwide in the United States. Healthcare facilities currently operating affected machines should immediately discontinue use and contact Fresenius Medical Care for repair or replacement instructions. Patients and facility staff should not operate machines with the listed affected serial numbers.
The recalled product
- Product
- 2008T BlueStar Hemodialysis Machine, Model 191124 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Category
- Medical Device — Hemodialysis
- Affected units
- 931
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Component: Model Number: F40015481 Rev A
- UDI/DI: N/A
- All Rev A lots. Finished Devices: Model Number: 191124
- UDI/DI: 00840861102082
- Serial Numbers: 0T0S252551
- 0T0S252801
- 0T0S252806
- 1T0S255908
- 1T0S256180
- 0T0S251792
- 0T0S251809
- 0T0S251811
- 0T0S252810
- 0T0S251585
- 0T0S251883
- 0T0S251899
- 1T0S256179
- 1T0S256183
- 1T0S256184
- 1T0S256185
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Fresenius Medical Care Holdings, Inc.
See all →- Moderate5008X Blood Tubing Set connection errors FDA Class II recall
FDA (Devices) · 2026-07-15
- HighBicarby dialysate bags carry an incorrect GTIN on the label
FDA (Devices) · 2026-06-17
- HighBicarby dialysate luer-lock connections may leak fluid onto floors
FDA (Devices) · 2026-06-17
- SevereDELFLEX Peritoneal Dialysis Solution Recall Due to Potential Sterility Issues
FDA (Drugs) · 2026-05-13
- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
Same hazard · component dislodgement
See all →- SevereFitRx adjustable dumbbell weight plates can dislodge from the handle
CPSC · 2026-04-23
- HighCellex photopheresis kit centrifuge bowls may dislodge and break
FDA (Devices) · 2026-04-22
- ModerateOxiris sets recalled over a deaeration chamber that may dislodge
FDA (Devices) · 2026-02-11
- ModeratePrismaflex M150 sets recalled over a deaeration chamber that may dislodge
FDA (Devices) · 2026-02-11
- ModeratePrismaflex M100 sets recalled over a deaeration chamber that may dislodge
FDA (Devices) · 2026-02-11
Similar recalls
- HighBlood Pump Rotor for Hemodialysis System Recalled for Loose Components
FDA (Devices) · 2024-07-17
- HighHemodialysis Blood Pump Rotor Spare Part Recalled for Loose Sheaves
FDA (Devices) · 2024-07-17
- HighHemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves
FDA (Devices) · 2024-07-17
- HighBlood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System
FDA (Devices) · 2024-07-17
- HighBlood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves
FDA (Devices) · 2024-07-17
- HighBlood Pump Rotor Spare Part Recalled for Loose Guide Sheaves
FDA (Devices) · 2024-07-17