FDA Device recall Z-3135-2026
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
- FDA Device
- Class II
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class II recall of Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25 by Nipro Renal Soultions Usa, citing hemodialysis concentrates contain high endotoxin levels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3135-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-05 |
| Published | 2026-09-16 |
| Last updated | 2026-09-23 05:30 UTC |
| Company | Nipro Renal Soultions Usa |
| Distribution | US |
Product
Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
Reason
Hemodialysis concentrates contain high endotoxin levels
Identifiers
| code_info | DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027),…DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-23 05:30 UTC. Current status: ongoing.
Other recalls by Nipro Renal Soultions Usa
- MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)
FDA Device · Class II · 2026-09-16 · Nipro Renal Soultions Usa - MedicaLyte Liquid Bicarbonate Concentrate
FDA Device · Class I · 2025-05-21 · Nipro Renal Soultions Usa - Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25
FDA Device · Class II · 2025-01-15 · Nipro Renal Soultions Usa
All Nipro Renal Soultions Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3135-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.