Nipro Renal Soultions Usa, Corporation: Dialysate Concentrate For Hemodialysis (liquid Or Powder)
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Product
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-08-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/30486978-b459-4983-b0ca-fe9f92c044f1