Fresenius Medical Care recalls
7 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for Fresenius Medical Care and put it in plain English.
Recent recalls
Fresenius CombiSet hemodialysis tubing needs instruction reviewFresenius Medical Care is issuing a communication regarding its CombiSet hemodialysis blood tubing set (Model 03-2522-1) to ensure healthcare providers and patients review the product's instructions for use. The company is recommending that all treatment preparation and handling steps be performed exactly as instructed to maintain safe operation.
ModerateFDASep 30, 2026
- GRANUFLO, NaturaLyte and Citrasate recalled for blue-green discoloration
Fresenius Medical Care is recalling three dialysis acid concentrate products, GRANUFLO, NaturaLyte and Citrasate, after complaints of blue-green discoloration in the product. No injuries have been reported. The products were distributed nationwide in the US and in Mexico.
ModerateFDASep 9, 20263 products
- Fresenius 5008X blood tubing sets recalled for blood leak risk
Fresenius Medical Care is recalling four 5008X blood tubing set models because the connection between the Arterial Alpha Clip and the main line or pump segment may leak blood during treatment. A leak could cause blood loss and low blood volume. No injuries have been reported.
ModerateFDASep 9, 20264 products
- Fresenius 2008T BlueStar hemodialysis machine recalled for alarm failures
Fresenius Medical Care has identified a problem with certain 2008T BlueStar hemodialysis machines that can cause flow, water supply, or temperature alarms to malfunction. These alarms are important safety features that alert clinical staff to problems during treatment. About 1,140 affected machines have been identified by serial number.
ModerateFDASep 2, 2026
- Fresenius Bicarby Dialysate recalled for GTIN labeling error
Fresenius Medical Care's Bicarby Dialysate (Model RFP-400-G) has incorrect barcode labeling on some units. While the case label and printed information are correct, scanning the GTIN barcode alone could lead to identification errors. This could result in use of a dialysate with a potassium concentration different from what was prescribed.
ModerateFDAJun 17, 2026
- Fresenius Bicarby Dialysate recalled for leak and slip hazard
Fresenius Medical Care is notifying users of potential leaks in Bicarby Dialysate products during setup and use. Fluid leaks from the luer-lock connection can create a slip and fall hazard on the floor where treatment is taking place.
ModerateFDAJun 17, 2026
- Stop using affected Fresenius 5008X CAREsystem units
Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.
SeriousFDADec 24, 2025