Class II

Medical Device Recall: Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25

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

7,770 cases

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3135-2026

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.

Nipro Renal Soultions USA, Corporation Medical Device Recall: Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 | SafeCheck