MedicaLyte Liquid Bicarbonate Concentrate recallZ-3133-2026 · Nipro Renal Soultions USA, Corporation · initiated Aug 5, 2026
Class II Open, Classified All recalls posted in September 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Nipro Renal Soultions USA, Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Hemodialysis concentrates contain high endotoxin levels
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-3133-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 5, 2026
- Posted by the FDA
- Sep 10, 2026
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Quantity
- 3,286 cases
- Product code
- KPO
- FDA submissions
- K012547
- 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 description
MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201
Code information (models, lots, serial numbers)
BC-100 - Lot:N4L022 (exp.11/13/2026), N4L037(exp.11/18/2026) BC+201- Lot: N4L010(exp.11/06/2026)
Other devices under the same FDA submission
2 devices cleared under K012547 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MedicaLyte BC+201Nipro Renal Solutions USA Corporation · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)1 recall1 death41 reports
- MedicaLyte BC+100Nipro Renal Solutions USA Corporation · Dialysate Concentrate For Hemodialysis (Liquid Or Powder)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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