FDA Alerts

Recall Alert: Baxter Permanently Removes Life2000 Ventilation System

Mon Dec 08 2025By FDA

The FDA is aware that Baxter is recalling the Life2000 Ventilation System due to a cybersecurity issue discovered through internal testing. If an unauthorized person were to gain physical access to an unattended device, they could potentially change device therapy settings or access device data. This may lead to the life-supporting air delivery function not working as intended.

Use of the affected product may cause serious adverse health consequences, including injuries caused by device malfunction or complete failure of vital breathing support and death.

As of April 10, 2025, Baxter has reported no serious injuries or deaths associated with this issue.

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