Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX
- Recalling company
- Fresenius Medical Care Holdings, Inc.
- Product
- 5008X CAREsystem +CLiC +CDX;
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 25, 2025
- Reported
- Dec 24, 2025
- Distribution
- Domestic: LA, MA, MN;
- Status
- Ongoing
- Quantity
- 115 units
- Lot / codes
- Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
- Company location
- Waltham, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0936-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0936-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.