Official recall notice
FDA DeviceClass IINotable
FDA Recall: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Recall date
- 2026-09-16
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Hemodialysis concentrates contain high endotoxin levels
Product description
Hemodialysis concentrates contain high endotoxin levels
Affected products
DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)