Nipro Renal Soultions USA, Corporation recalls MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Hemodialysis concentrates contain high endotoxin levels

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.

• FDA enforcement recordOfficial FDA database entry for Z-3133-2026
• FDA 510(k) clearance · K012547The device's official FDA premarket clearance record
• FDA device classification · KPOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.5820The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Nipro Renal Soultions USA, CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.