CareFusion AVEA ventilator, all models
Medical device recall Z-1609-2015. Published in FDA’s Enforcement Report on Jun 3, 2015.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 3, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 4 states named
- 15,905 units total (5,670 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are 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.
15,905 units total (5,670 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. AKV01874 AGV01443 AEV02197 AKV02580 AEV02375 BBV01304 BBV01303 AJV02510 AJV02502 AGV02650 AFV01802 AFV01792 AFV01400 AFV01361 AEV01622 AEV01608 AKV01915 BBV03730 BBV03557 BBV03556 BBV03554 BBV03553 BBV 3558 BBV01406 BBV01396…
Every code shown here, 2,000 characters
Serial No. AKV01874 AGV01443 AEV02197 AKV02580 AEV02375 BBV01304 BBV01303 AJV02510 AJV02502 AGV02650 AFV01802 AFV01792 AFV01400 AFV01361 AEV01622 AEV01608 AKV01915 BBV03730 BBV03557 BBV03556 BBV03554 BBV03553 BBV 3558 BBV01406 BBV01396 AHV01880 AGV02205 BBV01432 AFV01657 AFV01655 AFV01647 BAV05234 AHV03069 AGV02249 BBV03797 BAV06514 BDV01011 BDV01000 BCV01938 BAV04011 BAV04010 BAV04009 BAV04005 BAV04004 BAV04003 BAV04002 BAV01313 AKV04053 AJV02289 BAV04021 AEV02264 AEV02225 AEV02205 ADV06091 AKV02569 AHV01206 AKV04351 AKV04349 AKV02550 AGV01385 AHV03128 ADV04116 BBV06059 BBV06057 BAV05153 AFV01492 BBV01620 BDV01371 BAV06447 BAV06446 BAV06445 AEV01724 AEV01712 BAV06463 AEV01694 AJV02446 AGV02139 BAV04188 BAV04187 AKV01153 AKV01147 AEV02720 AEV02717 AEV02713 BAV04191 BAV04993 AHV02129 ADV06297 ADV01637 ADV01592 AFV01922 AFV02277 AHV01274 BAV05235 BCV02186 BCV01822 BBV06061 BDV01249 BDV01242 ADV03032 AJV01685 AHV01967 AHV01722 AHV01701 AKV02230 AKV02226 AKV02224 AKV02219 AKV02217 AKV02215 AKV02214 BEV01326 BEV01325 BEV01324 BEV01306 BEV01205 BDV02001 BDV01994 BDV01810 AKV01279 AKV04320 BAV06124 BBV03028 BBV03027 BBV01483 BBV01019 BBV01018 BBV01016 BAV01015 BAV01020 BBV01010 AKV01029 AKV01012 AKV01007 AKV01000 BCV02865 BAV01088 BAV01026 BAV01018 AKV01018 AKV01017 AHV03287 AHV03061 AFV02243 AFV02230 ADV01638 AGV01808 BFY01003 AGV02074 AFV01176 AKV04033 AEV01588 BAV01089 AKV01009 AKV01005 AFV02205 BBV01005 ACV01718 AKV01028 BFV01053 BEV02183 BAV01099 ADV06397 ADV03003 BAV04113 BAV04111 BEV02185 BEV02184 BDV01816 ajv01601 AGV01333 AGV01278 AFV01962 AHV01326 AJV02876 AEV02362 AEV02359 AEV02340 AFV01616 AFV01744 AFV01661 AFV01633 AFV01632 AFV01631 AFV01629 AFV01625 AFV01545 AFV01481 AFV01449 BEV01356 BEV01352 BDV02093 BCV01220 BCV01206 AGV02366 BBV06021 BBV06016 BBV06007 BBV06006 AEV02120 AKV01274 AKV01240 BCV01810 BCV01619 BCV01176 BCV01072 BCV01059 BCV01057 BBV03951 BBV03598 BBV03570 BAV04368 AKV01068 AKV01047 BAV04362 BDV01515 BDV01480 BEV01663 BEV01648 BCV02271 BCV02270…
FDA’s list runs to 111,200 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- American Samoa
- Georgia
- Guam
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 3, 2015.
- FDA classified it on May 26, 2015.
- FDA’s Enforcement Report published it on Jun 3, 2015.
- FDA terminated it on Jul 23, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Carefusion 211 Inc dba Carefusion, of Yorba Linda, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 111,200 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.