CareFusion EnVe and ReVel Ventilators — Class I medical device recall Z-2593-2014
Terminated recall by CareFusion 203, Inc., reported 2014-10-01, distributed nationwide. CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due
| Recall number | Z-2593-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 203, Inc., Minneapolis, MN, United States |
| Recall initiated | 2014-08-08 |
| Classified | 2014-09-19 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-10-07 |
| Distributed | Nationwide (US) |
| Quantity | 1,729 |
| Serial numbers | 48381, 48384, 48386, 48387, 48389, 48390, 48391, 48396, 48397, 48399, 48400, 48401, 48404, 48405, 48406, 48407, 48408, 48409, 48410, 50360, 50361, 50362, 50363, 50364, 50365 and 475 more |
Product
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is 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, transport and homecare as a source of continuous or intermittent positive pressure ventilator support, delivered invasively or non-invasively. These ventilators are restricted medical devices intended for operation by a trained personnel under the direction of a physician and in accordance with all applicable state laws and regulations.
Reason for recall
CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.