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FDAOctober 25, 2025device

5008X CAREsystem +CLiC +CDX;

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

fresenius medical carefreseniusfresenius medical

UPCs

00840861102433

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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