Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling specific lots of Granuflo Dry Acid Concentrate for hemodialysis due to the presence of a foreign substance.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a foreign substance without reported injuries or illnesses.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 92,225 units of Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL (Catalog Number: OFD2251-3B). The product is used for hemodialysis and was distributed nationwide in the United States and in Mexico.
The recall was initiated because discolored powder was found in the product, which confirmed the presence of a foreign substance. The affected lots are 18ETGF010, 18HTGF002, 18HTGF003, 18HTGF007, 18HTGF011, 18HTGF013, 18HTGF016, 18JTGF005, 18JTGF010, 18JTGF012, 18KTGF001, and 18KTGF011.
Healthcare facilities and consumers should stop using the affected product and contact the recalling firm for further instructions.
The recalled product
- Product
- Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis
- Hazard
- Affected units
- 92,225
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Fresenius Medical Care Renal Therapies Group, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Fresenius Medical Care Renal Therapies Group, LLC
See all →- ModerateFresenius CombiSet Hemodialysis Blood Tubing Set Recalled for Handling Review
FDA (Devices) · 2026-09-30
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius NaturaLyte Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- ModerateFresenius Citrasate Liquid Acid Concentrate Recalled for Discoloration
FDA (Devices) · 2026-09-09
- SevereFresenius 5008X HD/HDF Blood Tubing Set Recalled for Leak Risk
FDA (Devices) · 2026-09-09
Same hazard · foreign substance
See all →- ModerateHeritage Pharmaceuticals Recalls Clindamycin Palmitate Hydrochloride Due to Foreign Particles
FDA (Drugs) · 2026-08-19
- HighPrednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
FDA (Drugs) · 2026-07-08
- ModerateCorlanor Ivabradine Tablets Recalled for Foreign Substance Contamination
FDA (Drugs) · 2026-07-01
- LowHydroxyzine Hydrochloride Oral Solution recalled for foreign substance
FDA (Drugs) · 2026-07-01
- ModerateCorlanor ivabradine tablets recalled for presence of foreign substance
FDA (Drugs) · 2026-07-01
Similar recalls
- HighFresenius Recalls Granuflo Dry Acid Concentrate Due to Discoloration
FDA (Devices) · 2026-09-09
- LowFresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration
FDA (Devices) · 2013-01-23
- LowFresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration
FDA (Devices) · 2013-01-23
- SevereFresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis
FDA (Devices) · 2012-07-04
- HighHemodialysis Acid Concentrates Recalled After Freezing Exposure During Transport
FDA (Devices) · 2021-07-28
- SevereFresenius GranuFlo Dissolution Units Recalled for Fire Risk
FDA (Devices) · 2015-11-25