FDA Medical Device · Z-3087-2026

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

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 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525

Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6,624 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-3087-2026%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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