Nipro Renal Soultions USA, Corporation

FDA Regulatory Profile

Nipro Renal Soultions USA, Corporation appears in FDA public data with 6 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3134-2026, Class II) was initiated on Aug 5, 2026.

Summary

Total Recalls
6 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3134-2026Class IIMedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Aug 5, 2026
Z-3136-2026Class IICitric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Aug 5, 2026
Z-3135-2026Class IICitric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Aug 5, 2026
Z-3133-2026Class IIMedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Aug 5, 2026
Z-1730-2025Class IMedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic boApr 11, 2025
Z-0820-2025Class IICitric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25Nov 22, 2024