Fresenius recalls Granuflo Dry Acid Concentrate-2K 2.0 Ca 1 Mg 16.5 GAL (Lot 18ETGF005) due to discolored powder containing foreign substances. Affected hemodialysis patients should contact for remedy.
“Fresenius Granuflo Dry Acid Concentrate Recall: Discolored Powder Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69652-fresenius-granuflo-dry-acid-concentrate-recall-discolored-powder-hazard. Based on FDA recall #Z-0516-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0516-2019%22&limit=1).
The FDA announced on 2018-10-09 that Fresenius Medical Care Renal Therapies Group, LLC voluntarily recalled Fresenius Granuflo Dry Acid Concentrate for hemodialysis due to discolored powder containing a foreign substance. The Class III recall affects 4,752 units distributed nationwide in the U.S. and Mexico.
How to tell if you have it
Brand: Fresenius
Product: Fresenius Granuflo Dry Acid Concentate- 2K 2.0 Ca 1 Mg 16.5 GAL
Catalog Number: OFD2201-3B
Lot code: 18ETGF005
The hazard
The product contains discolored powder that has confirmed the presence of a foreign substance. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Fresenius Medical Care Renal Therapies Group, LLC has 15 other recalls on record since 2017-09-29. Other recent recalls of similar products include Diasol 100220-10-DEX1 Dialysis Acid Concentrate Recall (2025-11-05), MedicaLyte Bicarbonate Powder Recall (2026-08-05), and Diasol 100230-10-DEX1 Dialysis Acid Concentrate Safety Recall (2025-11-05).
How to tell if you have this one
Check for the product name 'Granuflo Dry Acid Concentrate-2K 2.0 Ca 1 Mg 16.5 GAL' and Lot code 18ETGF005. This product is used for hemodialysis.
Brand
Fresenius
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Distribution US nationwide and Mexico
Recall number
Product, codes & lots
Quantity
Z-0516-2019
Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis; Lot code:18ETGF005
4752
Z-0517-2019
Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B for hemodialysis; Lot code: 18ETGF010 18HTGF002 18HTGF003 18HTGF007 18HTGF011 18HTGF013 18HTGF016 18JTGF005 18JTGF010 18JTGF012 18KTGF001 18KTGF011
92225
Z-0518-2019
Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD3251-3B for hemodialysis; Lot code: 18BTGF016 18ETGF006 18ETGF014 18HTGF015 18LTGF003
22320
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the product name and Lot code 18ETGF005 to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Distribution US nationwide and Mexico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0516-2019 (October 9, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0516-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.