Class IIDeviceOngoing

Nipro Renal Soultions USA, Corporation

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

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Details

Recall number: Z-3134-2026
Event ID: 99573
Recall initiated: Aug 5, 2026
Classified: Sep 10, 2026
Reported: Sep 16, 2026
Quantity: 2,327 cases
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Lewisberry, PA, United States
Lot / code info: DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)