Fresenius 2008T BlueStar Hemodialysis Machine Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Fresenius Medical Care is recalling 1,140 units of 2008T BlueStar Hemodialysis Machines due to flow, no water, or temperature alarm complaints.
The full picture behind this FDA recall
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class II recall, with the stated reason "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.", distributed us nationwide distribution.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
It is tempting to skim, check personal relevance, and move on. The better habit is confirming scope, source, and timestamp first, then reading this alongside related notices instead of drawing a conclusion from one record alone.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Fresenius Medical Care Renal Therapies Group, LLC has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T BlueStar Hemodialysis machines.
Which Products Are Affected
The recall affects 1,140 systems distributed nationwide in the United States. Affected products are Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126 (UDI/DI 00840861102099) and 191130 (UDI/DI 00840861102112). Recall number Z-3017-2026. Specific serial numbers are listed in the FDA notice.
What You Should Do
Users experiencing alarms should contact the recalling firm for further instructions.
Why This Matters
The recall addresses potential functionality issues with hemodialysis machines used in patient treatment across the United States.
Source
FDA recall Z-3017-2026 (report date 20260902).
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (870 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to September 9, 2026.
Common Questions
Questions readers often have about this FDA recall.