FDA Reclassifies Fresenius 2008T BlueStar Dialysis Machine Recall as Class II
The agency changed the hazard classification for the Fresenius Medical Care 2008T BlueStar hemodialysis machine recall, now citing a remote chance of serious harm.
4 reports on this incident · first at Aug 28, 2026, 10:11 a.m. ET
Earlier reports
Aug 28, 2026, 10:21 a.m. ET
FDA Reports Injuries in Fresenius 2008T BlueStar Dialysis Machine Recall
The U.S. Food and Drug Administration (FDA) has reported that injuries have been reported in connection with the recall of Fresenius Medical Care 2008T BlueStar hemodialysis machines, according to an enforcement report published by the agency. The report, dated June 30, 2026, lists the recall as open and does not specify the number or nature of the injuries.
The recall, classified as Class II, affects 1,140 machines with model numbers 191126 and 191130, distributed nationwide. The FDA states that use of the affected machines may cause temporary or medically reversible health consequences, with serious harm considered unlikely. The manufacturer, Fresenius Medical Care Renal Therapies Group, initiated the recall after receiving complaints that the units can trigger flow, no-water, and temperature alarms during use.
The FDA advises users to use a back-up machine until the company can replace the parts. The recall number is Z-3017-2026. The agency's database records no other enforcement actions by this firm.
Aug 28, 2026, 10:16 a.m. ET
FDA Closes Recall of Fresenius 2008T BlueStar Hemodialysis Machines
The U.S. Food and Drug Administration has closed the recall of Fresenius Medical Care 2008T BlueStar hemodialysis machines, models 191126 and 191130, according to an FDA enforcement report. The agency considers the recall carried out. The recall, numbered Z-3017-2026, was initiated on June 30, 2026, and affected 1,140 units distributed nationwide.
The recall was classified as Class II, meaning use of the affected machines may cause temporary or medically reversible health consequences, with serious harm considered unlikely. The manufacturer received complaints that the units can trigger flow, no-water, and temperature alarms during use. The FDA has not published whether any patient injuries were reported.
The remedy advised is to use a back-up machine until Fresenius Medical Care Renal Therapies Group can replace the parts. The recall status is open, but the agency has closed the action. The FDA database records no other enforcement action by this firm.
Aug 28, 2026, 10:11 a.m. ETFirst report
FDA Class II Recall Issued for Fresenius 2008T BlueStar Hemodialysis Machines
The U.S. Food and Drug Administration (FDA) has classified as Class II a recall of Fresenius Medical Care 2008T BlueStar hemodialysis machines, identified by codes 191126 and 191130, initiated on June 30, 2026, according to a report by Medical Daily. The recall, number Z-3017-2026, covers 1,140 units distributed nationwide.
The manufacturer, Fresenius Medical Care Renal Therapies Group, received complaints that the units can trigger flow, no-water, and temperature alarms during use. The FDA's Class II classification indicates that use of the affected machines may cause temporary or medically reversible health consequences, with serious harm considered unlikely, as reported by Medical Daily. Regulators have not published whether any patient injuries were reported.
The FDA advises users to use a back-up machine until Fresenius Medical Care can replace the parts, according to the report. The recall status is open. The FDA's enforcement database lists no other enforcement action by this firm.
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