Nipro MedicaLyte Bicarbonate Powder Recalled for High Endotoxin Levels
Nipro Renal Solutions is recalling MedicaLyte Bicarbonate Powder due to high endotoxin levels. The recall affects 2,327 cases distributed in the US, Guatemala, and Panama.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (endotoxin) in a medical device without reported illness, which aligns with the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nipro Renal Solutions USA, Corporation is recalling 2,327 cases of MedicaLyte Bicarbonate Powder. The recall is due to the product containing high endotoxin levels. The affected product references are DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X).
The recalled product was distributed nationwide in the United States, specifically in Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio, and Pennsylvania. It was also distributed in Guatemala and Panama. The specific lots affected are NDB5E004 (expiration 4/30/2027), NDB5M011 (expiration 12/05/2027), and NDB4J003 (expiration 9/25/2026).
Consumers and healthcare providers should stop using the recalled product and contact Nipro Renal Solutions for further instructions or a replacement.
The recalled product
- Product
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Manufacturer
- Nipro Renal Soultions USA, Corporation
- Hazard
- Affected units
- 2,327
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- NDB4J003(exp.9/25/2026)
Distribution
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