FDA-Device2026-09-02Class IIPROCESSING DEFECT
Fresenius Medical Care 2008T BlueStar Hemodialysis Machine recalled for alarm malfunctions
What this means
Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.
- Check if your hemodialysis facility operates any 2008T BlueStar machines with the listed serial numbers (models 191126 or 191130)
- Contact Fresenius Medical Care for guidance on the specific issue affecting your unit and any recommended corrective actions
- Monitor alarm systems closely on affected machines until further instructions are received
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
1140 systems
Manufactured in
920 Winter St Bld 920, N/A, Waltham, MA, United States
Products
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3017-2026More Fresenius Medical Care recalls
- FDA-Device2026-09-30Fresenius CombiSet hemodialysis blood tubing set needs proper preparation review
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk during dialysis
- FDA-Device2026-09-09Fresenius 5008X HD/HDF blood tubing set recalled for blood leak risk
- FDA-Device2026-09-09Fresenius Citrasate Liquid Acid Concentrate recalled for blue-green discoloration
- FDA-Device2026-09-09Fresenius NaturaLyte Liquid Acid Concentrate for Hemodialysis recalled for blue-green discoloration
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