'Cyber Issue' Leads to FDA Recall of Baxter Respiratory Gear

Hackers Could Adjust Life Support Settings of At-Home Life 2000 Ventilation System Marianne Kolbasuk McGee (HealthInfoSec) • December 1, 2025

The Food and Drug Administration is warning that Life 2000 - an at-home ventilation system by medical device maker Baxter - has been permanently recalled due to a cyber issue that could allow individuals with physical access to tamper with the gear's life support settings.

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Baxter in April began notifying at-home patients about an unspecified cyber problem with their Life 2000 equipment, urging patients to reach out to their healthcare provider for therapy replacement options.

Baxter describes the Life 2000 as a portable, lightweight "mask-free non-invasive ventilator that is designed to provide breathing ...