GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B recall (Fresenius Medical Care Renal Therapies Group, LLC)
Medical deviceClass IIOngoing
Summary: Fresenius Medical Care Renal Therapies Group, LLC is recalling GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis. Reason: Complaints of blue-green discoloration in product.
What is being recalled
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Why
Complaints of blue-green discoloration in product
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the country of Mexico.
How to tell if yours is affected
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3091-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 14, 2026 |
| Reported | September 9, 2026 |
| Company | Fresenius Medical Care Renal Therapies Group, LLC |
| Company location | Waltham, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 27,216 cs; 2,316 ea |
More recalls from Fresenius Medical Care Renal Therapies Group, LLC · all medical device recalls · recalls from July 2026