FDA Product Recall

At Nipro Medical Corporation, safety and transparency are at the heart of everything we do. With the knowledge of the FDA, we are issuing a voluntary Class I medical device recall for all lots of our MedicaLyte™ Liquid Bicarbonate Concentrate (BC+201, 45X). This product, used in dialysis treatment, has been identified as having potential fungal and bacterial contamination.

On this page, you'll find the official recall letter, details on the scope and actions to take, and resources to support your response.

• Product: MedicaLyte™ Liquid Bicarbonate Concentrate

• Code: BC+201, 45X

• Recall Class: Class I

• Status: Voluntary Recall

• Issued By: Nipro Medical Corporation

• Date: May 29, 2025

• Scope: All lots since May 2023 (185 total)

• Reason: Microbial contamination risk

• Adverse Events: 2 serious, 3 reported

At Nipro, we remain steadfast in our commitment to patient safety, product quality, and open communication.  This voluntary recall reflects our values in action - acting swiftly, transparently, and with integrity.
We recognize the critical role our partners play in patient care and thank you for your understanding and cooperation as we work through this process together.

If you have questions or are ready to return affected product:

📦 Contact Sedgwick for Returns & Logistics
Phone: 1-877-546-0126
Return Address:
Sedgwick Brand Protection
Attn: Event 4621
2670 Executive Dr., Suite A
Indianapolis, IN 46241

Sincerely Yours,
Akira Shimizu - CEO Nipro Medical Corporation