Class II

Medical Device Recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis

Fresenius Medical Care Renal Therapies Group, LLC · July 14, 2026

Reason for Recall

Complaints of blue-green discoloration in product

Distribution

Worldwide distribution - US Nationwide and the country of Mexico.

States Affected

NATIONWIDE

Quantity Affected

27,216 cs; 2,316 ea

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3091-2026

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.

Fresenius Medical Care Renal Therapies Group, LLC Medical Device Recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis | SafeCheck