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FDA · Medical devices ·

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

Nipro Renal Soultions USA, Corporation recalled MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) on September 16, 2026 because of hemodialysis concentrates contain high endotoxin levels. It was sold nationwide.

Why it was recalled

Hemodialysis concentrates contain high endotoxin levels

What's recalled

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

Quantity: 2,327 cases

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Nipro Renal Soultions USA, Corporation, Lewisberry, PA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
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.
Status
Ongoing
Recall number
Z-3134-2026
Source
U.S. Food and Drug Administration

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