Recall Z-3133-2026— Nipro Renal Soultions USA, Corporation

Name: FDA recall Z-3133-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-05

Class II · Ongoing

Class II FDA medical device recall by Nipro Renal Soultions USA, Corporation, initiated 2026-08-05. It names one FDA 510(k) clearance: K012547. Product: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201. Reason: Hemodialysis concentrates contain high endotoxin levels.

Recalling firm: Nipro Renal Soultions USA, Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-08-05
Firm location: Lewisberry, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K012547 — HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTIONDi-Chem, Inc.·cleared 2002-01-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

Data sourced from openFDA. This site is unofficial and independent of the FDA.