FDA Medical Device · Z-3085-2026

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

Class II · Ongoing

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.

Affected lots / codes — check yours against thisLots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 62,544 units
Distribution: 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.
Recall initiated: August 10, 2026
Classified: September 2, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3085-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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