According to the FDA, Baxter issued an urgent medical device recall in April related to its ventilators. In a notice dated today, Nov. 26, 2025, the FDA said the company told customers to stop using the Life2000 systems. Patients should reach out to their healthcare provider to discuss replacement options.
The FDA identified this recall as its most serious type, as it can cause serious injury or death through continued use. As of April 10, 2025, Baxter reported no serious injuries or deaths associated with this issue.
Baxter acquired Life2000 through its $12.5 billion acquisition of Hillrom in 2021. It was designed to provide continuous or intermittent breathing support for people who require mechanical ventilation assistance. The system includes a ventilator and compressor and offers positive pressure ventilation for adults delivered through an endotracheal tube or a mask.
According to the FDA, Baxter recalled the system due to a cybersecurity issue discovered through internal testing. If an unauthorized person gained physical access to an unattended device, they could potentially change therapy settings or access data. This may lead to the failure of the life-supporting air delivery function to work as intended.
The 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.
Baxter’s decision to pull the ventilator from the market also follows previous recalls, including one in 2024 for potential battery charging issues, which followed a 2023 recall related to potential oxygen desaturation.
