Lower risk Medical device recall · FDA · Published August 8, 2024

Fresenius Medical Care - Medical Devices and Healthcare Solutions

Fresenius Medical Care is a leading global provider of medical devices and healthcare solutions, including dialysis machines, infusion systems, and more.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-3124-2024Medical device Fresenius Medical Care ›

Lower-risk recall

Machines equipped with BPM3 Blood Pressure Modules (Blood pressure monitor TM-2917B with firmware version S005) will not record Blood Pressure measurements and does not alarm if the cuff tubing is kinked close to the cuff.

Take action

Contact the company

Recalling firmFresenius Medical Care Holdings, Inc.920 Winter St Bld 920 · Waltham, MA 02451-1521

✎ GovInfoNow plain-language explainer

Fresenius Medical Care is a leading global provider of medical devices and healthcare solutions, including dialysis machines, infusion systems, and more. Read more at govinfonow.com/recall/54263-fresenius-medical-care-medical-devices-and-healthcare-solutions.

Source Summary by GovInfoNow · govinfonow.com/recall/54263-fresenius-medical-care-medical-devices-and-healthcare-solutions · Updated August 19, 2026 · FDA enforcement record: FDA #Z-3124-2024

Cite this page

“Fresenius Medical Care - Medical Devices and Healthcare Solutions.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54263-fresenius-medical-care-medical-devices-and-healthcare-solutions. Based on FDA recall #Z-3124-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3124-2024%22&limit=1).

The FDA has issued a Class II recall for Fresenius Medical Care Holdings, Inc. products due to labeling errors and potential leaks.

How to tell if you have it

Fresenius Medical Care Bicarby Dialysate
Fresenius 5008X Blood Tubing Set

The hazard

The recall addresses risks including slip and fall hazards from dialysate leaks, online port errors due to connection issues with the 5008X CAREset, and incorrect product identification due to GTIN labeling errors.

Context

Fresenius Medical Care Holdings, Inc. has 44 other recalls on record since 2014-04-14. Other recent similar recalls include risks of blood leaks during treatment for the 5008X Blood Tubing Set and HD/HDF with Twister/CLiC Blood Tubing Sets.

How to tell if you have this one

Check for any recent recalls or warnings from the manufacturer for specific models of dialysis machines.

Brand
Fresenius Medical Care
Category
Medical device

Based on the official FDA remedy

What to do — step by step

1
Verify if your dialysis machine model is listed in the recall notices from Fresenius Medical Care.
2
If the model is affected, contact Fresenius Medical Care customer support immediately for guidance on corrective actions.
3
Ensure that the machine is properly maintained and serviced according to the manufacturer's specifications.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide. Canada.” 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 published this recall 41 days after the firm started it.

Aug 8, 2024Firm started the recall
Sep 11, 2024FDA classified it Class II
Sep 18, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How often should I service my dialysis machine?

Follow the manufacturer's recommended maintenance schedule for your specific model of dialysis machine.

Similar recalls

Other Fresenius Medical Care recalls

Latest medical device recalls

Keep exploring

More Fresenius Medical Care recalls

Link to this recall

<a href="https://govinfonow.com/recall/54263-fresenius-medical-care-medical-devices-and-healthcare-solutions">Fresenius Medical Care - Medical Devices and Healthcare Solutions (GovInfoNow)</a>

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-3124-2024 (August 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3124-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.