Recall Z-3134-2026— Nipro Renal Soultions USA, Corporation

Name: FDA recall Z-3134-2026
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: K131202. 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.

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

K131202 — MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35XDialysis Medical Solutions, LLC·cleared 2014-04-03

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 Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))

Reason for recall

Hemodialysis concentrates contain high endotoxin levels

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