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Z-3134-2026Class II

Nipro Renal Soultions USA, Corporation

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Nipro Renal Soultions USA, Corporation
Product type
Device
Status
Ongoing
Report date
2026-09-16
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.
Firm state
PA
Product quantity
2,327 cases
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Product description

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

Code / lot 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)

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →