The FDA has posted 6 enforcement recalls from Nipro Renal Soultions USA, Corporation since 2025, including 1 Class I (most serious) recall. Most recent report: Sep 16, 2026.
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Hemodialysis concentrates contain high endotoxin levels
Potential for the presence of visible foreign matter.
The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Firm name as filed with the FDA: “Nipro Renal Soultions USA, Corporation”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.