Class 2 Device Recall MedicaLyte Bicarbonate Powder

• Date Initiated by Firm: August 05, 2026
• Date Posted: September 10, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3134-2026
• Recall Event ID: 99573
• 510(K)Number: K131202
• Product Classification: Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
• Product: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
• Code Information: DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
• FEI Number: 1000142899
• Recalling Firm/ Manufacturer: Nipro Renal Soultions USA, Corporation; 509 Fishing Creek Rd; Lewisberry PA 17339-9517
• For Additional Information Contact: Jessica Oswald-McLeod; 305-432-6699
• Manufacturer Reason for Recall: Hemodialysis concentrates contain high endotoxin levels
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KPO