Baxter has permanently recalled all Life2000 Ventilation Systems and compressors after discovering a serious cybersecurity risk. The FDA has classified this as a Class I recall — the most serious type.
What’s the danger?
Baxter found that anyone with physical access to an unattended Life2000 device could tamper with therapy settings or access patient data.
This could cause the ventilator to malfunction or stop providing life-supporting air, leading to severe injury or death.
No deaths or serious injuries have been reported so far.
Who is affected?
All serial numbers of the following devices:
- Life2000 Ventilator
Product codes: MS-01-0100, MS-01-0118 - Life2000 Compressor
Product codes: MS-01-0093, MS-01-0121, MS-01-0125
(A Life 2000 Ventilator is pictured below)
What you must do now
For home patients:
- Stop using the device immediately.
- Contact your healthcare provider to arrange replacement therapy.
- Once you have an alternative, call Baxter Home Care Customer Service at 800-426-4224 (option 3) to return the unit.
- Do not leave the ventilator unattended in public or unsecured places.
- If you think someone accessed your device, notify your care team and Baxter.
For healthcare facilities & DME suppliers:
- Locate all Life2000 units and discontinue use.
- Keep devices secured; report suspected tampering.
- Contact Baxter Acute Care Customer Service at 800-426-4224 (option 2, then option 1).
Why this recall matters
The Life2000 provides breathing support for adults who need mechanical ventilation at home or in care facilities. Because the device is life-sustaining, any unauthorized change to its settings can be catastrophic.
Support & Questions
- Home care patients: 800-426-4224 (option 3)
- Healthcare providers / distributors: 800-426-4224 (option 2, then option 1)
- Clinical support: 800-397-9071
