Class II — Nipro Renal Soultions USA, Corporation
| Recalling firm | Nipro Renal Solutions USA, Corp |
|---|---|
| Registered facility | Nipro Renal Solutions USA, Corporation (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Hemodialysis concentrates contain high endotoxin levels |
| Product | Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 |
| Quantity | 7,770 cases |
| 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. |
| Initiated | 2026-08-05 |
| Classified | 2026-09-10 |
| Recall number | Z-3135-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Nipro Renal Soultions USA, Corporation (Z-3135-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99573/
Alerts for Nipro Renal Solutions USA, Corp
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.