Respironics V60 Ventilator, Service # 850008
Medical device recall Z-1152-2020. Published in FDA’s Enforcement Report on Feb 19, 2020.
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 Feb 19, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2851 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Ventilator touchscreen may become frozen and fail to respond to touch commands. If a patient requires a change in therapy, there is no warning associated with an unresponsive touchscreen, and therefore the clinician would have no prior indication of a touchscreen failure and would be unable to change ventilator settings. The ventilator will continue to function at the predetermined and accepted settings required to support the patient. A delay in therapy adjustments may result in hypercarbia and/or hypoxemia.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614
2851, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 100005249 100254792 100255723 100255865 100256311 100256502 100256609 100256781 100256875 100257173 100257312 100257583 100257698 100258034 100258360 100258513 100258809 100259082 100259249 100259633 100259878 100260186…
Every code shown here, 1,996 characters
Serial Numbers: 100005249 100254792 100255723 100255865 100256311 100256502 100256609 100256781 100256875 100257173 100257312 100257583 100257698 100258034 100258360 100258513 100258809 100259082 100259249 100259633 100259878 100260186 100260534 100260846 100261115 100261278 100261538 100261743 100262170 100262417 100262531 100262627 100262821 100007779 100254793 100255724 100255866 100256312 100256503 100256610 100256782 100256876 100257174 100257313 100257584 100257699 100258035 100258361 100258514 100258810 100259083 100259250 100259634 100259879 100260231 100260535 100260847 100261117 100261279 100261539 100261744 100262171 100262418 100262532 100262628 100262822 100007982 100254977 100255725 100255965 100256313 100256504 100256611 100256783 100256877 100257175 100257314 100257585 100257800 100258159 100258362 100258553 100258811 100259085 100259251 100259635 100259880 100260233 100260537 100260849 100261120 100261302 100261540 100261745 100262172 100262419 100262533 100262629 100262823 100008795 100255098 100255726 100255966 100256314 100256505 100256612 100256784 100256980 100257176 100257316 100257586 100257801 100258211 100258363 100258554 100258812 100259086 100259252 100259636 100259881 100260234 100260538 100260850 100261121 100261320 100261541 100261746 100262173 100262420 100262534 100262630 100262824 100009556 100255165 100255727 100255967 100256315 100256507 100256613 100256785 100256981 100257177 100257317 100257587 100257802 100258240 100258364 100258556 100258813 100259087 100259253 100259724 100259882 100260235 100260539 100260851 100261122 100261321 100261543 100261747 100262174 100262421 100262535 100262631 100262825 100010513 100255317 100255728 100255968 100256316 100256508 100256614 100256786 100256982 100257178 100257318 100257588 100257803 100258241 100258365 100258557 100258814 100259088 100259255 100259726 100259996 100260236 100260540 100260852 100261123 100261322 100261544 100261748 100262175 100262422 100262536 100262632 100262826…
FDA’s list runs to 27,845 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.
US Nationwide. OUS (Foreign): Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Greece, Hong Kong, Iceland, India, Indonesia, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Singapore, South Africa, Spain, Sweden, United Arab Emirates, United Kingdom, Viet Nam, Oman, Philippines, Saudi Arabia, Taiwan, Turkey, Russian Federation, Argentina, Ecuador, Poland, Guatemala, Peru, Viet Nam
These words name no state.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Sep 11, 2019.
- FDA classified it on Feb 12, 2020.
- FDA’s Enforcement Report published it on Feb 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Respironics California, LLC, of Carlsbad, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
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 27,845 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
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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.