Fresenius Granuflo Dry Acid Concentrate Recall: Discolored Powder Hazard

Take action

Contact the company & request your remedy

Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St, N/A · Waltham, MA 02451-1521

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius is recalling Granuflo Dry Acid Concentrate-2K 2.0 Ca 1 Mg 16.5 GAL (Lot 18ETGF005) because discolored powder contains a foreign substance. This could pose a health risk during hemodialysis treatments.

Why it’s dangerous

The product contains discolored powder with a confirmed foreign substance. This could lead to health issues if the powder is used in hemodialysis treatments.

Who’s affected

Hemodialysis patients using this specific product are affected. Those with the Lot code 18ETGF005 are most at risk.

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

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.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall states discolored powder contains a foreign substance, so it is not safe to use.

What should I do if I have this product?

The recall remedy is not specified, so contact Fresenius for guidance.

How can I tell if I have the recalled product?

Look for the product name 'Granuflo Dry Acid Concentrate-2K 2.0 Ca 1 Mg 16.5 GAL' and Lot code 18ETGF005.

Take action

Contact Fresenius

We’ve drafted a message you can send Fresenius to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0516-2019 — Fresenius Fresenius

Hello,

I own a Fresenius that is covered by recall Z-0516-2019 from Fresenius.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

Where this comes from

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.

Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Recall notice