FDAAugust 10, 2026
Fresenius 5008X HD/HDF Blood Tubing Set Recall Over Blood Leak Risk
FDA published this notice on August 10, 2026 for United States.
This notice is kept at its address for anyone who saved the link. AreaZine no longer holds the agency's full record for it, so the page shows what AreaZine recorded and links to the agency's own page, the one to read.
What AreaZine recorded
- Agency
- FDA
- Place
- United States
- Date
- August 10, 2026
- Recall class
- Class II
- Reason given by the agency
- 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.
- 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.
- Official source
- the notice at its source
Official warnings by state, with every type counted since 2008Search notices, places and declaration numbers
Source: FDA.