FDA Medical devices recall ·
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8 recall
- Recall number
- Z-3087-2026
- Date
- (initiated August 10, 2026)
- Company / brand
- Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St Bld 920, Waltham, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6,624 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots 25JR01802 25NR01017 25NR01266 UDI-DI 00840861102525
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.
States: Alabama California Colorado Florida Georgia Illinois Kentucky Louisiana Massachusetts Maryland Minnesota Missouri North Carolina New Hampshire New York Ohio Pennsylvania Tennessee Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3087-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.