MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 recall (Nipro Renal Soultions USA, Corporation)
Medical deviceClass IIOngoing
Summary: Nipro Renal Soultions USA, Corporation is recalling MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201. Reason: Hemodialysis concentrates contain high endotoxin levels.
What is being recalled
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Why
Hemodialysis concentrates contain high endotoxin levels
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Florida, Georgia, Illinois, Maryland, Michigan, North Carolina, New Jersey, Nevada, Ohio, Pennsylvania)
How to tell if yours is affected
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3133-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 5, 2026 |
| Reported | September 16, 2026 |
| Company | Nipro Renal Soultions USA, Corporation |
| Company location | Lewisberry, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,286 cases |
More recalls from Nipro Renal Soultions USA, Corporation · all medical device recalls · recalls from August 2026