Reported Sep 2, 2026 · Ongoing · Updated Sep 16, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Medical Care Renal Therapies Group, LLC · 920 Winter St Bld 920 · Waltham, MA · 02451-1521
Is this the product you have?
- Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine
- Model Numbers
191126191130
- Lot codes and dates
191126UDI/DI 00840861102099
- Serial Numbers
247 of 247 codes
5T0S2911165T0S2911195T0S2911255T0S2911355T0S2911375T0S2911385T0S2911395T0S2911405T0S2911415T0S2911435T0S2911445T0S2911455T0S2911465T0S2911485T0S2911495T0S2911505T0S2911515T0S2911525T0S2911545T0S2911555T0S2911565T0S2911575T0S2911585T0S2911595T0S2911605T0S2911615T0S2911625T0S2911635T0S2911645T0S2911655T0S2911665T0S2911685T0S2911695T0S2911705T0S2911735T0S2911775T0S2911785T0S2911795T0S2911805T0S2911815T0S2911825T0S2911835T0S2911845T0S2911855T0S2911865T0S2911875T0S2911885T0S2911895T0S2911905T0S2911915T0S2911925T0S2911935T0S2911945T0S2911955T0S2911965T0S2911975T0S2911985T0S2911995T0S2912005T0S291201
- Serial Numbers
894 of 894 codes
6T0S2917196T0S2918166T0S2918426T0S2918446T0S2918506T0S2918566T0S2918576T0S2918596T0S2918616T0S2918746T0S2918846T0S2918936T0S2918996T0S2919016T0S2919026T0S2919036T0S2919046T0S2919056T0S2919066T0S2919076T0S2919086T0S2919096T0S2919106T0S2919116T0S2919126T0S2919136T0S2919146T0S2919156T0S2919166T0S2919176T0S2919186T0S2919196T0S2919206T0S2919216T0S2919226T0S2919236T0S2919246T0S2919256T0S2919266T0S2919276T0S2919286T0S2919296T0S2919306T0S2919316T0S2919326T0S2919336T0S2919346T0S2919356T0S2919366T0S2919376T0S2919386T0S2919396T0S2919406T0S2919416T0S2919426T0S2919436T0S2919446T0S2919456T0S2919466T0S291947
- Amount recalled
- 1140 systems
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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