Recall Z-0936-2026 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
5008X CAREsystem +CLiC +CDX;
| Date | Dec 17, 2025 (initiated Oct 25, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | On Octiber 25, 2025, customers were called and read a Medical Device Recall Script. Instructions: Please examine the 5008X CAREsystems at your location to confirm that you have any of this product: 1. Please segregate this product until the software update can be performed. 2. Please provide the number of 5008X CAREsystems you have installed at your clinic and the serial numbers of the devices. If the customer has any additional medical concerns or questions, please have them contact Medical Information and Communication: 855-616-2309 or Website: www.freseniusmedinfo.com. Report any complaints |
| Quantity | 115 units |
| Distribution | Domestic: LA, MA, MN; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243505 | 5008X Hemodialysis System Fresenius Medical Care Renal Therapies Group, LLC, May 30, 2025 |