- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Reason for recall
- Hemodialysis concentrates contain high endotoxin levels
- Affected products (lot / model / serial)
- DB+201-2.1: Lot -NDB5E004(exp.4/30/2027) DB+201-25: Lots - NDB5M011(Exp.12/05/2027, NDB4J003(exp.9/25/2026)
- Units affected
- 2,327 cases
- 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.
- Firm location
- Lewisberry, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3134-2026
- Recall initiated
- August 5, 2026
- FDA classification date
- September 10, 2026
- FDA report date
- September 16, 2026
- FDA event ID
- 99573
- Last updated on HTM Vibe
- September 23, 2026