Class II

Medical Device Recall: Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.

Fresenius Medical Care Renal Therapies Group, LLC · June 30, 2026

Reason for Recall

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.

Distribution

US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

1140 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3017-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.