Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported July 25, 2012
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.
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 Patie…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
CareFusion 203, Inc. recalled CareFusion EnVe Ventilator Designed for use on patients who require respiratory suppor… - a critical-severity action.
CareFusion EnVe Ventilator Designed for use on patients who require respiratory suppor… was recalled by CareFusion 203, Inc. in July 25, 2012. Reason: CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) v…. Check the official notice for the remedy. Verify recall #Z-2006-2012 with the FDA Devices before acting.
The recall
CareFusion 203, Inc. issued this critical-severity FDA Devices recall-CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) v….
- Critical
- severity level
- 266 units
- affected scope
- Class I
- classification
- July 25, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2006-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2006-2012) was formally reported on July 25, 2012, with the manufacturer initiating the action on June 19, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. CareFusion 203, Inc. is listed as the recalling firm, operating out of Minneapolis, MN. Federal records list the affected scope as 266.
The documented reason for this recall is: 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 activat… Distribution data in the federal record shows the product reached: Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
266
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2006-2012 |
| Date reported | July 25, 2012 |
| Date initiated | June 19, 2012 |
| Recalling firm | CareFusion 203, Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 266 |
| Distribution | Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2006-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by CareFusion 203, Inc.. Units affected: 266.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2012. Severity: Critical. Recall number: Z-2006-2012.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AZ, CA, CO, FL, IL, KY, ME, MI, MO, MN, MT, ND, NJ, NM, NV, NY, OK, PA, SC, SD, TX , UT, WI, and WV..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2006-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.