Fresenius Medical Care
3 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Fresenius Medical Care and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-17FDA-DeviceClass IIFresenius Bicarby Dialysate recalled for GTIN labeling error
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result.
- 2026-06-17FDA-DeviceClass IIFresenius Bicarby Dialysate recalled for leak and slip hazard
Given the increased number of leaks reported by users, it was determined to be the appropriate course of action to notify users of the potential for the occurrence of Bicarby luer-lock leaks during manipulation of the frangible and tubing when preparing the product for use for treatment. This issue presents the potential of a slip and fall hazard associated with fluid on the floor.
- 2025-12-24FDA-DeviceClass IIStop using affected Fresenius 5008X CAREsystem units
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
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