Fresenius Medical Care Renal Therapies Group recall: GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more products
Fresenius Medical Care Renal Therapies Group, LLC is recalling GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more products – 27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 ea. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on July 14, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B and 2 more products |
| Brand | Fresenius Medical Care Renal Therapies Group |
| Company | Fresenius Medical Care Renal Therapies Group, LLC |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 14, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 27,216 cs; 2,316 ea; 2,998 cs; 68 ea; 56,036 cs; 1,788 drums; 204 ea |
| Recall ID | 99543 |
Recalled products (3)
- GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
- FDA recall number
- Z-3091-2026
- Codes, lots and dates
- 1) 0FD2251-3B, UDI/DI 00840861101535, Lot Numbers: 26AXGF015, 26AXGF016, 26AXGF017, 26BXGF008, 26BXGF009; 2) 0FD3251-3B, UDI/DI 00840861101597, Lot Numbers: 26AXGF014, 26AXGF018.
- Quantity
- 27,216 cs; 2,316 ea
- Classification
- Class II
- NaturaLyte, 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 Acid Concentrate for Bicarbonate Hemodialysis
- FDA recall number
- Z-3092-2026
- Codes, lots and dates
- 1) 08-1251-1, UDI/DI 00840861101658, Lot Numbers: 26AXAC056; 2) 08-2251-0, UDI/DI 00840861101696, Lot Numbers: 26AXAC050, 26BXAC012, 26BXAC042; 3) 08-2301-3, UDI/DI 00840861101702, Lot Numbers: 26BXAC013, 26BXAC045; 3) 08-3251-9, UDI/DI 00840861101740, Lot Numbers: 26AXAC051, 26BXAC011, 26BXAC043; 4) 08-3301-2, UDI/DI 00840861101757, Lot Numbers: 26AXAC052; 5) 13-2201-5, UDI/DI 00840861101849, Lot Numbers: 26AXAC062, 26AXAC064; 6) 13-2251-0, UDI/DI 00840861101863, Lot Numbers: 26AXAC041, 26AXAC058, 26AXAC059, 26AXAC065, 26BXAC001, 26BXAC003, 26BXAC005, 26BXAC034, 26BXAC049, 26BXAC051; 7) 13-3251-9, UDI/DI 00840861101887, Lot Numbers: 26BXAC037, 26BXAC048.
- Quantity
- 2,998 cs; 68 ea
- Classification
- Class II
- Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
- FDA recall number
- Z-3093-2026
- Codes, lots and dates
- 1) 08-2251-CA, UDI/DI 00840861101344, Lot Numbers: 26BXAC038; 2) 08-3251-CA, UDI/DI 00840861101351, Lot Numbers: 26BXAC039; 3) 13-2251-CA, UDI/DI 00840861101375, Lot Numbers: 26BXAC040, 26BXAC041.
- Quantity
- 56,036 cs; 1,788 drums; 204 ea
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99543
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Waltham, MA, United States
Why it was recalled
The reason the FDA lists: “Complaints of blue-green discoloration in product”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide and the country of Mexico.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99543, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Fresenius Medical Care Renal Therapies Group recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Fresenius Medical Care Renal Therapies Group recall: CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer ProtectorsMedical devices · 1743026 units | Communication to recommend reviewing the IFU and ensuring that all treatment preparation a… Serious | FDA Class II |
| Sep 9, 2026 | Fresenius Medical Care Renal Therapies Group recall: 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6 and 3 more productsMedical devices · 120 units; 62,544 units; 18,600; 6,624 units | Heightened probability of blood leak from the connection between the Arterial Alpha Clip a… Serious | FDA Class II |
| Sep 2, 2026 | Fresenius Medical Care Renal Therapies Group recall: Fresenius Medical CareMedical devices · 1140 systems | Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regardi… Serious | FDA Class II |
All 4 Fresenius Medical Care Renal Therapies Group recalls →
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About this recall
Is Fresenius Medical Care Renal Therapies Group GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B recalled?
Yes. Fresenius Medical Care Renal Therapies Group, LLC recalled it on July 14, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Complaints of blue-green discoloration in product
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.