CareFusion EnVe Ventilator Designed for use on patients who require… — Class I medical device recall Z-2006-2012
Terminated recall by CareFusion 203, Inc., reported 2012-07-25, distributed nationwide. CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) va
| Recall number | Z-2006-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 203, Inc., Minneapolis, MN, United States |
| Recall initiated | 2012-06-19 |
| Classified | 2012-07-16 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2013-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 266 |
| Serial numbers | 26562, 43634, 43642, 43643, 44536, 44537, 44540, 44541, 44542, 44543, 44544, 44545, 44546, 44552, 44553, 44554, 44555, 44557, 44558, 44559, 44560, 44561, 44562, 44563, 44564 and 241 more |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2006-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.