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Recall Alert: Baxter Permanently Removes Life2000 Ventilation System
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.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Home care customers and/or patients in the U.S. with adverse reactions, quality problems, or questions about this recall should contact the Home Care Customer Service team at 800-426-4224 and select option 3, or Baxter Clinical Support at 800-397-9071.
Healthcare providers, DME suppliers, and distributors should contact Baxter Acute Care Customer Service team at 800-426-4224 and select option 2, followed by option 1.
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