- Recalling firm
- Nipro Renal Soultions USA, Corporation
- Reason for recall
- Hemodialysis concentrates contain high endotoxin levels
- Affected products (lot / model / serial)
- DCA+200-25 : Lots - NDC5E015(Exp.5/20/2027), NDC5E016(Exp.5/21/2027), NDC5E017(Exp.5/22/2027), NDC5E019(Exp.5/29/2027), NDC5E012(Exp.5/19/2027), NDC5B017(Exp.2/24/2027), NDC5C023(Exp.3/24/2027) DCA+203-25: NDC5C026(Exp.3/27/2027), NDC5L026(Exp.11/17/2027)
- Units affected
- 7,770 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-3135-2026
- 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