Class II

Medical Device Recall: NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for

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

Reason for Recall

Complaints of blue-green discoloration in product

Product Description

NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for Bicarbonate Hemodialysis

Distribution

Worldwide distribution - US Nationwide and the country of Mexico.

States Affected

NATIONWIDE

Quantity Affected

2,998 cs; 68 ea

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3092-2026

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.