FDA announces full recall of Baxter Life2000 ventilators over cybersecurity flaw

Chad Van Alstin | November 26, 2025 | Health Exec | Supply Chain

The U.S. Food and Drug Administration (FDA) has issued a recall on behalf of Illinois-based healthcare company Baxter, which is removing its Life2000 Ventilation Systems from the market after it was discovered they have a potentially dangerous cybersecurity flaw.

According to the FDA, this vulnerability could allow an unauthorized person to access the pumps, where they would then have the power to change settings and effectively control operations. Because ventilators are used as life-saving tools to support breathing, any malicious alteration of settings on the devices could be fatal.

Baxter said it discovered the issue during its own internal testing and has no evidence that there have been any serious injuries or deaths associated with the security flaw. All the same, a patch is apparently not enough to solve the problem. This recall has been given the FDA’s most serious designation, and the systems need to be removed from supply houses and patient care settings immediately.

It’s unclear if this security issue allows someone to hack into the pumps remotely or if they would need physical access. However, Baxter is asking all providers to ensure that the pumps are secured and, if in use, they’re monitored at all times to reduce the likelihood of tampering.

Alternatives should be obtained immediately, as all Life2000 units will need to be returned to Baxter, as they are not safe to use.

What is being recalled?

All Life2000 Ventilation Systems are subject to this emergency recall. See the chart below for a complete list of models and serial numbers.

Next Steps

The FDA instructions are clear: “Stop using Life2000 ventilators.” They are not to be left unattended. This warning applies to homecare patients and provider facilities alike.

Anyone in possession of the units is asked to contact Baxter to facilitate a return and refund:

Home care customers and/or patients: Home Care Customer Service team at 800-426-4224, option 3, or Baxter Clinical Support at 800-397-9071.
Healthcare providers, DME suppliers, and distributors: Baxter Acute Care Customer Service team at 800-426-4224, option 2, then option 1

Baxter said it sent a notice to all known customers on April 10, 2025 that contained more detailed instructions. For more information, read the full FDA recall notice by clicking here.