Fresenius Medical Care Renal Therapies Group recalls

4 official recalls and safety alerts involving Fresenius Medical Care Renal Therapies Group since 2026-09, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Fresenius Medical Care Renal Therapies Group or the relevant agency.

1. 2026-09-30
2. US
   Drugs & medicalClass II

   Fresenius Medical Care Renal Therapies Group, LLC recalls CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors; Model Number:…

   Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.

   FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCDomestic: Nationwide Distribution;Official notice →
3. 2026-09-09
4. US
   Drugs & medicalClass II

   Fresenius Medical Care Renal Therapies Group, LLC recalls GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B; 0FD3251-3B; Dry Acid Concentrate for Bicarbonate…

   Complaints of blue-green discoloration in product

   FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCWorldwide distribution - US Nationwide and the country of Mexico.Official notice →
5. US
   Drugs & medicalClass II

   Fresenius Medical Care Renal Therapies Group, LLC recalls 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.

   FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCWorldwide - US Nationwide distribution in the states of AL, CA, CO, FL, GA,…Official notice →
6. 2026-09-02
7. US
   Drugs & medicalClass II

   Fresenius Medical Care Renal Therapies Group, LLC recalls 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.

   FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCUS Nationwide distribution.Official notice →