FDAFDA recall Z-3087-2026 · Sep 9, 2026
Fresenius Medical Care Renal Therapies Group, LLC: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall
Recall found
Product
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
- 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.
- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-10
Source: openFDA enforcement record Z-3087-2026 · search recall number Z-3087-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.