MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
FDA Recall Z-3133-2026 · Posted 2026-09-10
Recalling FirmNipro Renal Soultions USA, Corporation
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2026-08-05
Product Quantity3,286 cases
Reason for Recall
Hemodialysis concentrates contain high endotoxin levels
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.