OVERLOOKED

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Class IIOngoing

Fresenius Medical Care Renal Therapies Group, LLC recalls 4 products

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Fresenius Medical Care Renal Therapies Group, LLC
Reason
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99556…

Products (4)

  1. 5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6

    Codes/lots: Lots 25KR01227 25NR01257 UDI-DI 00840861102556Quantity: 120 unitsRecall no. Z-3084-2026Class II

  2. 5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3

    Codes/lots: Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518Quantity: 62,544 unitsRecall no. Z-3085-2026Class II

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

    Codes/lots: Lots 25JR01801 25KR01225 25KR01251 25NR01016 25NR01265 UDI-DI 00840861102532Quantity: 18,600Recall no. Z-3086-2026Class II

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

    Codes/lots: Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525Quantity: 6,624 unitsRecall no. Z-3087-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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