FDA Medical Device Recalls (openFDA)
Nipro Renal Soultions USA, Corporation: MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Recall number
- Z-3134-2026
- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Product
- MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))
- Status
- Open, Classified
- Initiated
- 2026-08-05
- Posted
- 2026-09-10
- Terminated
- not on file
- Reason
- Hemodialysis concentrates contain high endotoxin levels
- Root 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
- 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.
- Lot, serial or model codes
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- 510(k) numbers
- ["K131202"]
- PMA numbers
- not on file
- Product code
- KPO
- Firm FEI
- 1000142899
- Firm city
- Lewisberry
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28