Puritan Bennett 980 Series Ventilator
Medical device recall Z-0966-2022. Published in FDA’s Enforcement Report on May 4, 2022.
- 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 May 4, 2022. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 18,508 OUS; 18,412 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?
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Puritan Bennett 980 Series Ventilator
18,508 OUS; 18,412 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35B2014314 10884521171633 35B1500319 10884521201408 35B1500321 10884521201521 35B1500322 10884521201408 35B1500323…
Every code shown here, 2,000 characters
Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35B2014314 10884521171633 35B1500319 10884521201408 35B1500321 10884521201521 35B1500322 10884521201408 35B1500323 10884521201408 35B1500324 10884521201408 35B1500718 10884521201408 35B1500744 10884521201408 35B1500758 10884521201408 35B1500773 10884521201408 35B1502000 10884521212251 35B1502094 10884521201354 35B1502099 10884521201354 35B1502104 10884521201354 35B1502172 10884521201224 35B1600140 10884521201224 35B1600170 10884521201224 35B1600182 10884521201224 35B1600188 10884521201224 35B1600198 10884521201224 35B1600202 10884521201224 35B1600203 10884521201224 35B1600204 10884521201224 35B1600209 10884521201224 35B1600211 10884521201224 35B1600213 10884521212251 35B1600216 10884521201224 35B1600217 10884521201897 35B1600218 10884521201910 35B1600221 10884521201224 35B1600225 10884521201224 35B1600228 10884521201224 35B1600242 10884521201224 35B1600251 10884521201224 35B1600274 10884521201224 35B1701370 10884521201408 35B1701377 10884521201408 35B1701395 10884521201408 35B1701429 10884521201408 35B1701445 10884521201408 35B1701451 10884521201408 35B1701495 10884521201408 35B1702271 10884521201521 35B1702336 10884521201521 35B1703244 10884521201521 35B1703347 10884521201521 35B1703348 10884521201521 35B1703354 10884521201521 35B1800087 10884521201408 35B1800112 10884521201408 35B1800114 10884521201408 35B1800129 10884521201408 35B1800130 10884521201408 35B1800131 10884521201408 35B1800132 10884521201408 35B1801327 10884521201408 35B1801345 10884521201408 35B1801362 10884521201521 35B1801381 10884521201408 35B1801393 10884521201408 35B1801396 10884521201408 35B1801407 10884521201521 35B1801409 10884521201521 35B1900064 10884521201408 35B1900072 10884521201408 35B1900116 10884521201408 35B1900121 10884521201408 35B1900129 10884521201408 35B1900682 10884521201408 35B1900693 10884521201408 35B1900694 10884521201408 35B1920013 10884521201408 35B1920029…
FDA’s list runs to 959,961 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 - Worldwide .Distribution
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 Mar 25, 2022.
- FDA classified it on Apr 24, 2022.
- FDA’s Enforcement Report published it on May 4, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic formerly Covidien, of Galway, Ireland.
- 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 959,961 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.