Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
CareFusion EnVe Ventilator Designed for use on patients who require Recalled by CareFusion 203, Inc. Due to CareFusion identified that the EnVe Ventilator may not...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CareFusion 203, Inc. directly.
Affected Products
CareFusion EnVe Ventilator Designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs). It is suitable for service in hospital and transport environments as a source of continuous or intermittent positive pressure ventilatory support, delivered invasively or non-invasively. It is not intended for homecare use.
Quantity: 266
Why Was This Recalled?
CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CareFusion 203, Inc.
CareFusion 203, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report