Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall: Flow, No Water
Recall of Fresenius Medical Care 2008T BlueStar Hemodialysis Machines with model numbers 191126 and 191130 due to flow, no water, or temperature-related alarms.
Use caution until it’s fixed
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.
What happened, in plain English
Fresenius Medical Care is recalling specific models of 2008T BlueStar Hemodialysis Machines (model numbers 191126 and 191130) because users have reported flow, no water, or temperature-related alarms. These issues could lead to improper dialysis treatment if not addressed. Read more at govinfonow.com/recall/697965-fresenius-medical-care-2008t-bluestar-hemodialysis-machine-recall-flow-no.
Source Summary by GovInfoNow · govinfonow.com/recall/697965-fresenius-medical-care-2008t-bluestar-hemodialysis-machine-recall-flow-no · Updated September 14, 2026 · FDA enforcement record: FDA #Z-3017-2026
Cite this page
“Fresenius Medical Care 2008T BlueStar Hemodialysis Machine Recall: Flow, No Water.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697965-fresenius-medical-care-2008t-bluestar-hemodialysis-machine-recall-flow-no. Based on FDA recall #Z-3017-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3017-2026%22&limit=1).
Why it’s dangerous
The machines may malfunction and trigger flow, no water, or temperature alarms, which could indicate improper dialysis function. If these alarms are not resolved, patients might receive inadequate treatment or experience complications.
Who’s affected
People who own or use the recalled 2008T BlueStar Hemodialysis Machines with model numbers 191126 or 191130 are affected. Patients undergoing dialysis are most at risk due to potential treatment disruptions.
How to tell if you have this one
Check if your machine has model numbers 191126 or 191130. The serial numbers listed in the recall include many specific combinations starting with 5T0S or 6T0S.
- Brand
Fresenius Medical Care- Category
Medical device
What to do — step by step
Check Machine Model
Verify your machine's model number to see if it matches 191126 or 191130.
Contact Manufacturer
Reach out to Fresenius Medical Care for guidance on resolving the alarms or potential replacement.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-3017-2026 (June 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3017-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.