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Medical device recall · FDA · Published July 29, 2026

Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;

Fresenius Medical Care recalls CombiSet hemodialysis tubing sets with model 03-2522-1. Review instructions to ensure safe use; no immediate action needed but check for proper handling.

🇺🇸 FDA recall #Z-3225-2026Medical deviceFresenius Medical Care ›
✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Medical Care is recalling CombiSet hemodialysis blood tubing sets with model number 03-2522-1. The recall is due to a need to review the user manual to ensure proper handling steps are followed. This does not pose an immediate risk but requires attention to safety instructions. Read more at govinfonow.com/recall/1292706-fresenius-medical-care-combiset-hemodialysis-tubing-set-recall-review-instructions.

Source Summary by GovInfoNow · govinfonow.com/recall/1292706-fresenius-medical-care-combiset-hemodialysis-tubing-set-recall-review-instructions · Published October 6, 2026 · Updated October 6, 2026 · FDA enforcement record: FDA #Z-3225-2026

Cite this page

“Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall: Review Instructions.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/1292706-fresenius-medical-care-combiset-hemodialysis-tubing-set-recall-review-instructions. Based on FDA recall #Z-3225-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3225-2026%22&limit=1).

Why it’s dangerous

The recall recommends reviewing the user manual to ensure all treatment preparation and handling steps are performed correctly. This is a procedural reminder rather than a physical defect that could cause injury.

Who’s affected

Patients undergoing hemodialysis and healthcare providers who use the CombiSet tubing sets with model number 03-2522-1 are affected. Those most at risk are individuals who have not reviewed the instructions for proper handling.

How to tell if you have this one

Check for the model number 03-2522-1 on the tubing set. The product was sold with specific lot codes listed in the recall notice.

  • Brand
    Fresenius Medical Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Review Instructions

    Read the user manual carefully to ensure all treatment preparation and handling steps are followed as instructed.

✎ GovInfoNow

Questions people ask

Do I need to stop using this product?

No, the recall does not require stopping use. Reviewing instructions is the only action needed.

What model number should I check?

Check for model number 03-2522-1 on the CombiSet hemodialysis blood tubing set.

Is there a risk of injury?

The recall focuses on ensuring proper handling steps are followed; there is no stated risk of injury from the product itself.

Take action

Contact Fresenius Medical Care

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

Subject: Recall Z-3225-2026 — Fresenius Medical Care Fresenius Medical Care

Hello,

I own a Fresenius Medical Care that is covered by recall Z-3225-2026 from Fresenius Medical Care.

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.

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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-3225-2026 (July 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3225-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on October 6, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA