Class II

Medical Device Recall: 5008X CAREsystem +CLiC +CDX;

Fresenius Medical Care Holdings, Inc. · October 25, 2025

Reason for Recall

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.

Distribution

Domestic: LA, MA, MN;

States Affected

LA, MA, MN

Quantity Affected

115 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0936-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Fresenius Medical Care Holdings, Inc. Medical Device Recall: 5008X CAREsystem +CLiC +CDX; | SafeCheck