Fresenius Medical Care Renal Therapies Group, LLC Recalls
9 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (9)
- Class II
August 10, 2026
5008X HD/HDF with CLiC Blood Tubing Set Part number 03-5300-3C
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.
- Class II
August 10, 2026
5008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number 03-5110-6
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.
- Class II
August 10, 2026
5008X HD/HDF Standard Blood Tubing Set Part Number 03-5300-3
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.
- Class II
August 10, 2026
5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8
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.
- Class II
July 29, 2026
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number: 03-2522-1;
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
- Class II
July 14, 2026
NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0, 08-2301-3, 08-3251-9, 08-3301-2, 13-2201-5, 13-2251-0, 13-3251-9; Liquid Acid Concentrate for
Complaints of blue-green discoloration in product
- Class II
July 14, 2026
Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA, 13-2251-CA; Liquid Acid Concentrate for Bicarbonate Hemodialysis
Complaints of blue-green discoloration in product
- Class II
July 14, 2026
GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate Hemodialysis
Complaints of blue-green discoloration in product
- Class II
June 30, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.