Skip to main content

FDA recall, , Moderate risk

Fresenius Medical Care 5008X Blood Tubing Sets

Blood tubing sets may leak at the connection, causing blood loss and hypovolemia.

Summary by Recall Canary from the FDA notice

What happened

Fresenius Medical Care Renal Therapies Group, LLC, of Waltham, Massachusetts, recalled certain 5008X blood tubing sets because of a heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. A leak during treatment may lead to blood loss and hypovolemia.

The company began the recall on August 10, 2026, and the FDA added it to the Enforcement Report on September 2, 2026. The affected products include the 5008X HD/HDF Standard Blood Tubing Set, the 5008X HD/HDF with CLiC Blood Tubing Set, the 5008X Standard HD Pre-Flush Standard Blood Tubing Set, and the 5008X HD/HDF with Twister Blood Tubing Set.

Distribution was worldwide, including US nationwide in states such as Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, and Virginia, as well as the country of Lithuania.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is your set affected?

4 products

Match the UDI-DI and lot code listed under your product.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

    UDI-DI
    • 00840861102518
    Lot code
    • 25JR01800
    • 25KR01224
    • 25LR01001
    • 25NR01018
    • 25NR01272
    • 25PR01077
    • 25PR01219
    • 25PR01220

  2. 5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C

    UDI-DI
    • 00840861102532
    Lot code
    • 25JR01801
    • 25KR01225
    • 25KR01251
    • 25NR01016
    • 25NR01265

  3. 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

    UDI-DI
    • 00840861102556
    Lot code
    • 25KR01227
    • 25NR01257

  4. 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

    UDI-DI
    • 00840861102525
    Lot code
    • 25JR01802
    • 25NR01017
    • 25NR01266

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution in the states of Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and the country of Lithuania.

Company
Fresenius Medical Care Renal Therapies Group, LLCWaltham, Massachusetts
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99556
Recall numbers
Z-3084-2026 to Z-3087-2026

All recalls from Fresenius Medical Care Renal Therapies Group, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Same product, other recalls

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)