FDAFDA · Food and drugs·Recall number Z-3134-2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Published September 16, 2026 · Recall initiated: August 5, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Hemodialysis concentrates contain high endotoxin levels
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Distributor
- 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.
- Lot
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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