Nipro Renal Soultions USA, Corporation
Nipro Renal Soultions USA, Corporation has 3 FDA enforcement events on this register (6 product records) between 2024 and 2026: 3 device; the busiest year was 2024 with 1.
33% of its events are Class I; the most common class is Class II (2). 3 events are listed as ongoing; the recalling firm's address is in PA.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 5 Aug 2026 | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 | Device | Class II | 4 | Ongoing |
| 11 Apr 2025 | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). | Device | Class I | 1 | Ongoing |
| 22 Nov 2024 | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | Device | Class II | 1 | Ongoing |
By type and class
Class I: 33% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Nipro Renal Soultions USA, Corporation had?
3 enforcement events (6 product records) on this register, 2024–2026: 3 device.
Are any Nipro Renal Soultions USA, Corporation recalls ongoing?
3 events are listed as ongoing in the current openFDA export.
What class are Nipro Renal Soultions USA, Corporation recalls?
2 Class II, 1 Class I. 33% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.