Recall archive / FDA device enforcement
5008X CAREsystem +CLiC +CDX; — FDA record Z-0936-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 25, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 115 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0936-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: LA, MA, MN;
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Dec 24, 2025
- Recall initiation date
- Oct 25, 2025
- Center classification date
- Dec 17, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.