Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Product Name: AVEA¿ Ventilator. All Models. The affected devices are Recalled by Carefusion 211 Inc dba Carefusion Due to CareFusion has identified a potential risk associated with...
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 211 Inc dba Carefusion directly.
Affected Products
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Quantity: 19,546 units
Why Was This Recalled?
CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Carefusion 211 Inc dba Carefusion
Carefusion 211 Inc dba Carefusion has 14 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report