- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Reason for recall
- Complaints of blue-green discoloration in product
- Affected products (lot / model / serial)
- 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
- Units affected
- 27,216 cs; 2,316 ea
- Distribution pattern
- Worldwide distribution - US Nationwide and the country of Mexico.
- Firm location
- Waltham, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3091-2026
- Recall initiated
- July 14, 2026
- FDA classification date
- September 3, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99543
- Last updated on HTM Vibe
- September 15, 2026