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FDA · Medical devices ·

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall

Fresenius Medical Care Renal Therapies Group, LLC recalled 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 on September 9, 2026 because of heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. It was sold nationwide.

Why it was recalled

Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may lead to blood loss and hypovolemia.

What's recalled

5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Quantity: 6,624 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Worldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA, IL, KY, LA, MA, MD, MN, MO, NC, NH, NH, NY, OH, PA, TN, TX, VA and the country of Lithuania.
Status
Ongoing
Recall number
Z-3087-2026
Source
U.S. Food and Drug Administration

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