Class II

Medical Device Recall: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Nipro Renal Soultions USA, Corporation · August 5, 2026

Reason for Recall

Hemodialysis concentrates contain high endotoxin levels

Distribution

Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.

States Affected

NATIONWIDE

Quantity Affected

2,327 cases

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3134-2026

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.