Baxter International Inc. (NYSE:BAX) recalled the Life2000 Ventilation system from the market after identifying a cybersecurity vulnerability that federal regulators say could lead to severe patient harm.
The U.S. Food and Drug Administration (FDA) classified the action as its most serious recall type, warning that unauthorized access to the device could disrupt life-supporting ventilation.
The company instructed all users to stop using the Life2000 ventilators immediately.
Patients were advised to contact their clinicians to determine alternative treatment plans and to avoid leaving the devices unattended or in unsecured locations.
The recall was formally communicated on April 10, 2025, through an Urgent Medical Device Recall letter sent to all affected customers.
Baxter said the issue came to light during internal cybersecurity testing, which revealed that someone with physical access to an unattended device could potentially alter therapy settings or access sensitive operational data.
Also Read: Baxter Trims Annual Outlook Again, Stock Hits 52-Week
According to the company, tampering could cause the ventilator to deliver air incorrectly or fail outright, posing risks that include severe injury or death.
Baxter reported no serious injuries or fatalities tied to the cybersecurity flaw as of the date of the notice.
The Life2000 system provides continuous or intermittent ventilation for adult patients requiring mechanical respiratory support.
It consists of the Life2000 Ventilator and the Life2000 Compressor and is designed for use in clinical settings or at home under the supervision of trained medical personnel.
The system is not approved for use in ambulances or air transport.
Baxter said it will continue providing replacement chargers for users affected by a separate battery-related issue identified in a February 2025 correction.
Those replacements will remain available until all Life2000 units are fully removed from circulation. However, the company stated it will not make additional updates to address a prior October 2024 correction related to missing low gas pressure alarms.
BAX Price Action: Baxter stock is up 0.24% at $18.70 at publication on Wednesday.
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