5008X CAREsystem +CLiC +CDX recallZ-0936-2026 · Fresenius Medical Care Holdings, Inc. · initiated Oct 25, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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 or adverse events to [email protected] or FDA MedWatch at https://www.fda.gov/safety/medical-product-safety-information/medwatchforms-fda-safety-reporting
Recall details
- Recall number
- Z-0936-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 25, 2025
- Posted by the FDA
- Dec 17, 2025
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 115 units
- Product code
- KDI
- FDA submissions
- K243505
- Distribution
- Domestic: LA, MA, MN;
Product description
5008X CAREsystem +CLiC +CDX;
Code information (models, lots, serial numbers)
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- 5008X Hemodialysis Machine M204441Fresenius Medical Care Renal Therapies Group, LLC · Dialyzer, High Permeability With Or Without Sealed Dialysate System1 recall4 reports
Other devices under the same FDA submission
5 devices cleared under K243505 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- 5008X 03-5300-3Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls23 reports
- 5008X 03-5300-3CFresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls6 reports
- 5008X 03-5350-8Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls0 reports
- 5008X 03-5110-6Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve2 recalls0 reports
- 5008X 04-3000-9Fresenius Medical Care Renal Therapies Group, LLC · Set, Tubing, Blood, With And Without Anti-Regurgitation Valve1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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