Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported October 1, 2014
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
CareFusion 203, Inc. recalled CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use … - a critical-severity action.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use … was recalled by CareFusion 203, Inc. in October 1, 2014. Reason: CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due…. Check the official notice for the remedy. Verify recall #Z-2593-2014 with the FDA Devices before acting.
The recall
CareFusion 203, Inc. issued this critical-severity FDA Devices recall-CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due….
- Critical
- severity level
- 2K units
- affected scope
- Class I
- classification
- October 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2593-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2593-2014) was formally reported on October 1, 2014, with the manufacturer initiating the action on August 8, 2014. 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 1729.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI.. 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
1729
Related Recalls
6
3 from same agency
Product description
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-2593-2014 |
| Date reported | October 1, 2014 |
| Date initiated | August 8, 2014 |
| Recalling firm | CareFusion 203, Inc. |
| Firm location | Minneapolis, MN |
| Affected scope | 1729 |
| Distribution | Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI. |
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-2593-2014) 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 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.. Recalled by CareFusion 203, Inc.. Units affected: 1729.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2014. Severity: Critical. Recall number: Z-2593-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including AL, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MS,M0, NE, NV,NH,NH, NY NMC, OH, OR,PA, RID, SC, TN, TX, UT VT, VA, WA, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2593-2014) 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 October 1, 2014. 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.