Fresenius Kabi USA, LLC: Pump, Infusion

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Tags

FDA recall, medical device, class 2, General Hospital, Software design, Open, Classified

Related exam domains

CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security

Source record id

Z-0885-2026

First seen by InfoSec Signals

Sep 23, 2026

Source: openFDA device recalls, U.S. Food and Drug Administration · about this source · more from it

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