UnratedMedical device recall · FDA · Published August 5, 2026
Nipro MedicaLyte Bicarbonate Concentrate Recall: High Endotoxin Risk
Nipro Renal Solutions recalls MedicaLyte Liquid Bicarbonate Concentrate (BC-100 and BC+201) due to high endotoxin levels that could cause health issues during hemodialysis.
“Nipro MedicaLyte Bicarbonate Concentrate Recall: High Endotoxin Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/1009704-nipro-medicalyte-bicarbonate-concentrate-recall-high-endotoxin-risk. Based on FDA recall #Z-3133-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3133-2026%22&limit=1).
Nipro Renal Solutions USA Corporation voluntarily recalled MedicaLyte Liquid Bicarbonate Concentrate due to high endotoxin levels, the FDA said on Aug. 5, 2026. The recall affects products distributed in the U.S., Guatemala, and Panama.
The hemodialysis concentrates contain high endotoxin levels. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show Nipro Renal Solutions USA Corporation has two other recalls on record since Nov. 22, 2024. Other recent recalls of similar products include Medline medical procedure kits recalled for potential endotoxin levels (March 19, 2026) and Spectra Medical Devices Sodium Chloride Injection Recall: Risk of Infection from Contaminated Solution (July 6, 2026).
How to tell if you have this one
Check for the product name 'MedicaLyte Liquid Bicarbonate Concentrate' with model numbers BC-100 or BC+201. Look for lot numbers N4L022, N4L037, or N4L010 on the packaging.
Brand
Nipro Renal Solutions
Category
Medical device
FDA recall event · 4 products
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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.
Identify the product name, model number, and lot number on the packaging to confirm if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, Georgia, Illinois, Maryland, Michigan, Nevada, New Jersey, North Carolina, Ohio, Pennsylvania.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3133-2026 (August 5, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3133-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.