Fresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
Fresenius Medical Care is recalling Granuflo Dry Acid Concentrate for hemodialysis due to confirmed foreign substance contamination.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 4,752 units of Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL (Catalog Number: OFD2201-3B). This product is used for hemodialysis.
The recall was initiated because discolored powder was found in the product, which confirmed the presence of a foreign substance. The affected lot code is 18ETGF005.
The product was distributed in the United States nationwide and in Mexico. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis
- Hazard
- Affected units
- 4,752
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot code:18ETGF005
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 →- HighFresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
FDA (Devices) · 2026-09-02
- HighFresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
FDA (Devices) · 2019-08-14
- LowFresenius 2008T BlueStar Hemodialysis Machines Recalled for Power Logic Board Fail Message
FDA (Devices) · 2019-06-12
- HighFresenius Optiflux F160NR Dialyzers Recalled for Potential Blood Leaks
FDA (Devices) · 2018-12-26
- ModerateFresenius Granuflo Dry Acid Concentrate Recalled for Foreign Substance
FDA (Devices) · 2018-12-05
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