Life2000 Ventilator System Recall: Risk of Patient Desaturation
Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as Class I, which establishes a minimum severity score of 4 per the rubric rule that FDA Class I recalls never go below 4. Although no illnesses or injuries are reported in the source material, the potential for patient desaturation in a critical care ventilator device represents a serious patient safety risk.
Plain-English summary
Baxter Healthcare Corporation is recalling 4,279 Life2000 Ventilator Systems (REF BT-20-0002 and BT-20-0002A) distributed nationwide.
There is a potential for patient desaturation events (dangerously low blood oxygen levels) to occur in certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator. This safety risk prompted an FDA Class I recall classification.
Patients and healthcare facilities using the Life2000 Ventilator System should contact Baxter Healthcare Corporation or the FDA for guidance on this issue. The manufacturer can provide specific information about affected serial numbers and recommended actions.
The recalled product
- Product
- Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- patient-desaturation
- hypoxia
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) REF BT-20-0002
- UDI 00887761978089
- Serial Numbers: 120370002037
- 120370001516
- 120370001522
- L2005055-910
- 120300000056
- 120370002035
- 120370001529
- 120370001518
- 120370001514
- 120370001909
- 120370001971
- 120360000581
- 120370001980
- 120370002002
- 120380000643
- 120370001975
- 120370002042
- 120370002030
Distribution
Distributed nationwide across the United States.
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