Nipro Renal Solutions USA, Corp
3 recall(s) on record — most severe on record: Class I.
Recalls by year
- Recalls (3)
Registered facilities (1)
- Nipro Renal Solutions USA, Corporation FEI 1000142899 · PA
Recalls & enforcement
- Class IIOngoing2026-08-05Hemodialysis concentrates contain high endotoxin levels
- Class IOngoing2025-04-11Potential for the presence of visible foreign matter.
- Class IIOngoing2024-11-22The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Nipro Renal Solutions USA, Corp — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10035998-nipro-renal-solutions-usa-corp/
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