FDA Device recall Z-3134-2026
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- FDA Device
- Class II
- ongoing
- Published 2026-09-16
On 2026-09-16 the FDA classified a Class II recall of MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X)) by Nipro Renal Soultions Usa, citing hemodialysis concentrates contain high endotoxin levels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3134-2026 |
| 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
MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Reason
Hemodialysis concentrates contain high endotoxin levels
Identifiers
| code_info | DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026) |
|---|
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
- Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25
FDA Device · Class II · 2026-09-16 · 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 - 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-3134-2026%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.