DOTmed September 12, 2025
When Baxter initiated a Class I recall of its Life2000 ventilators, it wasn’t the first cybersecurity-related recall we’d seen in the industry. But it was a clear sign that the FDA now treats cybersecurity vulnerabilities the same way it treats other high-risk safety issues. This wasn’t a low-acuity product. These were ventilators used in complex, high-risk clinical environments. And Baxter didn’t wait to be told to take action. They disclosed the issue via ICS-CERT and on their own website before initiating the formal recall process, which was a proactive move that shows just how seriously many manufacturers are starting to treat cybersecurity.
That recall can be seen as a signal. The FDA is codifying a shift we’ve felt coming for...
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