FDA-Device2026-09-16Class IIPROCESSING DEFECT
Nipro MedicaLyte Bicarbonate Powder recalled for high endotoxin levels in hemodialysis concentrate
What this means
Nipro Renal Solutions USA is recalling specific lots of MedicaLyte Bicarbonate Powder used in hemodialysis treatment. The powder contains higher-than-safe levels of endotoxins, which are bacterial contaminants that can cause serious reactions in patients undergoing dialysis. The affected lots were distributed nationwide and internationally.
- If you use or administer this product, check the lot number and expiration date against the recall notice.
- Contact your dialysis provider or Nipro immediately if you have this product in use.
- Do not use affected lots; follow your provider's instructions for safe replacement concentrate.
The agency's original wording
Hazard
Hemodialysis concentrates contain high endotoxin levels
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
2,327 cases
Manufactured in
509 Fishing Creek Rd, Lewisberry, PA, United States
Products
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3134-2026More Nipro recalls
- FDA-Device2026-09-16Nipro Citric Complete Dry Citric Acid Concentrate recalled for high endotoxin levels
- FDA-Device2026-09-16Nipro Renal Solutions Citric Complete hemodialysis concentrate recalled for high endotoxin levels
- FDA-Device2026-09-16Nipro MedicaLyte Liquid Bicarbonate Concentrate recalled for high endotoxin levels in hemodialysis concentrate
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