Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported June 3, 2015
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ve…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Carefusion 211 Inc dba Carefusion recalled CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respi… - a critical-severity action.
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respi… was recalled by Carefusion 211 Inc dba Carefusion in June 3, 2015. Reason: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm.…. Check the official notice for the remedy. Verify recall #Z-1609-2015 with the FDA Devices before acting.
The recall
Carefusion 211 Inc dba Carefusion issued this critical-severity FDA Devices recall-A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm.….
- Critical
- severity level
- 16K units
- affected scope
- Class I
- classification
- June 3, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1609-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1609-2015) was formally reported on June 3, 2015, with the manufacturer initiating the action on April 3, 2015. It is classified under Critical severity (Class I), with a current status of Terminated. Carefusion 211 Inc dba Carefusion is listed as the recalling firm, operating out of Yorba Linda, CA. Federal records list the affected scope as 15,905 units total (5,670 units in US).
The documented reason for this recall is: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathin… Distribution data in the federal record shows the product reached: Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia H…. 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
15,905 units total (5,670 units in US)
Related Recalls
6
3 from same agency
Product description
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Reason for recall
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1609-2015 |
| Date reported | June 3, 2015 |
| Date initiated | April 3, 2015 |
| Recalling firm | Carefusion 211 Inc dba Carefusion |
| Firm location | Yorba Linda, CA |
| Affected scope | 15,905 units total (5,670 units in US) |
| Distribution | Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, … |
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-1609-2015) 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 AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.. Recalled by Carefusion 211 Inc dba Carefusion. Units affected: 15,905 units total (5,670 units in US).
Why was this product recalled? ▼
A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 3, 2015. Severity: Critical. Recall number: Z-1609-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Egypt, El Salvadore, Estonia, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Rep), Kuwait, Latvia, Lebanon, Libyan Jamahiriya, Lithuania, Malaysia, Mexico, Moldova, Morocco, Nepal, Netherlands, Nicaragua, Norway, Occupied Palestinian Territory, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, Spain, South Africa, South America, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, and Yemen..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1609-2015) 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 June 3, 2015. 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.