FDA Medical devices recall ·
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B recall
- Recall number
- Z-3091-2026
- Date
- (initiated July 14, 2026)
- Company / brand
- Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St Bld 920, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 27,216 cs; 2,316 ea
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Why was it recalled?
Complaints of blue-green discoloration in product
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
Distribution
Worldwide distribution - US Nationwide and the country of Mexico.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3091-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.