Nipro Renal Soultions USA, Corporation

FDA Regulatory Profile

Nipro Renal Soultions USA, Corporation appears in FDA public data with 2 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1730-2025, Class I) was initiated on April 11, 2025.

Summary

Total Recalls
2 (1 Class I)
510(k) Clearances
0
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1730-2025Class IMedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic boApril 11, 2025
Z-0820-2025Class IICitric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25November 22, 2024