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November 26, 2025
The FDA said Baxter is permanently removing its Life2000 ventilators from the market due to a cybersecurity flaw.
The company said that if an unauthorized person were to gain physical access to the device while it is unattended, they could potentially change device therapy settings or access device data. That could result in the life-supporting air delivery function not working as intended.
Baxter said use of 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.
The full removal notice is available here.
