News

The FDA has announced that Baxter (NYSE: BAX) has instructed customers to stop using its Life2000 ventilators.

The agency reported that Baxter issued an urgent medical device recall in April regarding the Life2000 system. In a notice dated Nov. 26, 2025, the FDA confirmed that the company is now directing all customers to discontinue use of the devices. Patients are advised to contact their healthcare providers to discuss replacement options.

The FDA classified the recall as its most serious level, indicating a risk of severe injury or death if the devices continue to be used. As of April 10, 2025, Baxter said it had received no reports of serious injuries or fatalities connected to the issue.

Baxter obtained the Life2000 technology through its $12.5 billion acquisition of Hillrom in 2021. The system was intended to deliver continuous or intermittent breathing support for adults needing mechanical ventilation, using a ventilator and compressor to provide positive pressure ventilation via an endotracheal tube or mask.

According to the FDA, Baxter initiated the recall after internal testing revealed a cybersecurity vulnerability. If someone gained physical access to an unattended device, they could alter therapy settings or access sensitive data. Such interference could prevent the device from delivering life-sustaining airflow as designed.

Use of the affected ventilators may lead to serious health risks, including injuries from device malfunction, complete loss of essential respiratory support, and potentially death.

Baxter’s market withdrawal follows earlier recalls involving the Life2000 system, including a 2024 recall over potential battery charging problems and a 2023 recall related to possible oxygen desaturation.