GranuFlo recallZ-3091-2026 · Fresenius Medical Care Renal Therapies Group, LLC · initiated Jul 14, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Renal Therapies Group, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints of blue-green discoloration in product
FDA root cause category: Material/Component Contamination
What the company is doing
Fresenius Medical Care issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/15/2026 via USPS first class mail. The notice explained the issue, potential risk and requested the following action: "1. Identify if you have any affected product lots on hand. 2. IMMEDIATELY segregate and discontinue use of affected lots. 3. Contact FMCRTG (1-833-203-5448) between 8:00 AM 8:00 PM Eastern daily, for return of affected lots and replacement of your stock. 4. Complete and return the attached REPLY FORM." For any clinical or medical questions, please contact the Global Medical Information and Education Office at 1-855-616-2309.
Recall details
- Recall number
- Z-3091-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 14, 2026
- Posted by the FDA
- Sep 3, 2026
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- Quantity
- 27,216 cs; 2,316 ea
- Product code
- KPO
- FDA submissions
- K192209
- Distribution
- Worldwide distribution - US Nationwide and the country of Mexico.
Product description
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Code information (models, lots, serial numbers)
1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- GranuFlo 0FD2251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death20 reports
- GranuFlo 0FD3251-3BFresenius Medical Care Renal Therapies Group, LLC · DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)2 recalls1 death1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 99543).
- Z-3092-2026 · Open, ClassifiedNaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid …
- Z-3093-2026 · Open, ClassifiedCitrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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