Z-3134-2026Class II

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

Name: Z-3134-2026 MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Creator: Nipro Renal Soultions USA, Corporation
Published: 2026-08-05
License: https://open.fda.gov/license/

Nipro Renal Soultions USA, Corporation / initiated 2026-08-05 / Open, Classified

FDA source

Recall record

Recall number: Z-3134-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-05
Posted: 2026-09-10
Recalling firm: Nipro Renal Soultions USA, Corporation
Product: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
Product code: KPO Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Reason for recall: Hemodialysis concentrates contain high endotoxin levels
FDA root cause: Process control
Action: On August 6, 2026 Nipro Medical Corporation issued a Urgent Medical Device Recall notification via Email. Nipro asked consignees to take the following actions: 1. Immediately examine your inventory for the affected product codes and lot numbers listed on the Recall response form. 2. Immediately segregate, quarantine, and discontinue use or distribution of any affected product in your possession. 3. Do not use, sell, transfer, or distribute affected products. 4. Complete the enclosed Recall Response Form within 10 business days, even if you do not have affected product on hand. 5. Contact Nipro customer service for product return and credit, if applicable. 6. If you distributed affected product, promptly notify your customers, provide them with a copy of this recall notice, and request that they complete and return the response form or equivalent confirmation. 7. Product Return or Disposition: Affected products should remain quarantined until return, destruction, or other documented disposition instructions are provided by Nipro. Please retain all documentation related to product quarantine, return, destruction, or other disposition for recall reconciliation.
Quantity in commerce: 2,327 cases
Distribution: Worldwide - US Nationwide distribution in the states of FL, GA, IL, MD, MI, NC, NJ, NV, OH, PA, and the countries of Guatemala and Panama.
Product codes and lots: DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3134-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3133-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10
Z-3134-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10
Z-3135-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10
Z-3136-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-16	2026-09-10

Product code KPO

K131202Class IIMedicalyte(r) Bicarbonate Powder (36.83X), Medicalyte(r) Bicarbonate Powder (45X), Medicalyte(r) Bicarbonate Powder (35XDialysis Medical Solutions, LLC / cleared 2014-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)