Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX;

Recall date

October 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0936-2026

FDA classification

Class II

Brand / firm

Fresenius Medical Care Holdings, Inc.

Sold / distributed

Domestic: LA, MA, MN;

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

5008X CAREsystem +CLiC +CDX;