- Recalling firm
- Fresenius Medical Care Renal Therapies Group, LLC
- 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.
- Affected products (lot / model / serial)
- Lots 25JR01800 25KR01224 25LR01001 25NR01018 25NR01272 25PR01077 25PR01219 25PR01220 UDI-DI 00840861102518
- Units affected
- 62,544 units
- Distribution pattern
- 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.
- Firm location
- Waltham, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- N/A
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3085-2026
- Recall initiated
- August 10, 2026
- FDA classification date
- September 2, 2026
- FDA report date
- September 9, 2026
- FDA event ID
- 99556
- Last updated on HTM Vibe
- September 15, 2026