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Lower risk Medical device recall · FDA · Published November 4, 2021

Covidien Puritan Bennett 980 Series Ventilator Recall: Manufacturing Error May Cause

Covidien recalls Puritan Bennett 980 Series ventilators with specific serial numbers due to a manufacturing error that may cause the device to become inoperable during use. Affected units include serial numbers 35B1700627-35B1700632.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0351-2022Medical deviceCovidien ›
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Contact the company

Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113
✎ GovInfoNow plain-language explainer

Covidien has recalled specific models of Puritan Bennett 980 Series ventilators because a manufacturing error could make them inoperable during use. This recall affects ventilators with serial numbers starting with 35B1700627 through 35B1700632. Read more at govinfonow.com/recall/61564-covidien-puritan-bennett-980-series-ventilator-recall-manufacturing-error-may.

Source Summary by GovInfoNow · govinfonow.com/recall/61564-covidien-puritan-bennett-980-series-ventilator-recall-manufacturing-error-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0351-2022

Cite this page

“Covidien Puritan Bennett 980 Series Ventilator Recall: Manufacturing Error May Cause.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61564-covidien-puritan-bennett-980-series-ventilator-recall-manufacturing-error-may. Based on FDA recall #Z-0351-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0351-2022%22&limit=1).

The FDA announced on November 4, 2021, that Covidien LLC is recalling the Puritan Bennett 980 Series Ventilator and 980X2ESDIEC due to a manufacturing assembly error. This defect may cause the device to become inoperable during use.

How to tell if you have it

  • Brand: Covidien
  • Product: Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
  • GTIN/UDI: 10884521174177
  • Serial Numbers: 35B1700627, 35B1700628, 35B1700629, 35B1700630, 35B1700631, 35B1700632

The hazard

According to the FDA, a capacitor within the ventilator was assembled incorrectly. This manufacturing assembly error may cause the device to become inoperable during use.

Context

GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls of similar products include Draeger Atlan A350 Anesthesia Workstation Recall (May 7, 2026) and Draeger Atlan A350XL Anesthesia Workstation Recall (May 7, 2026).

How to tell if you have this one

Check if your ventilator has serial numbers starting with 35B1700627 through 35B1700632. The product is part of the Puritan Bennett 980 Series with GTIN/UDI 10884521174177.

  • Brand
    Covidien
  • Category
    Medical device
FDA recall event · 16 products

All 16 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Terminated
  • Distribution
    Worldwide distribution - US Nationwide.
Recall numberProduct, codes & lots
Z-0338-2022Puritan Bennett 980 Series Ventilator, 980A1ENNISB; GTIN/UDI - 10884521201897 Serial Numbers: 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508 & 35B1701569.
Z-0339-2022Puritan Bennett 980 Series Ventilator, 980A3ENNISB; GTIN/UDI - 10884521201910 Serial Numbers: 35B1700246, 35B1700543, 35B1700887
Z-0340-2022Puritan Bennett 980 Series Ventilator, 980S1ENDICU; GTIN/UDI - 10884521171114 Serial Numbers: 35B1700409 35B1700443 35B1700457 35B1700462 35B1700473 35B1700476 35B1700483 35B1700487 35B1700490 35B1700511 35B1700552 35B1700567 35B1700569 35B1700570
Z-0341-2022Puritan Bennett 980 Series Ventilator, 980S3ENDICU; GTIN/UDI - 10884521171244 Serial Numbers: 35B1700406 35B1700449 35B1700467 35B1700469 35B1700471 35B1700474 35B1700481 35B1700526 35B1700558
Z-0342-2022Puritan Bennett 980 Series Ventilator, 980U1ENASAA; GTIN/UDI - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663
Z-0343-2022Puritan Bennett 980 Series Ventilator, 980U1ESDIUC; GTIN/UDI - 10884521201415 Serial Numbers: 35B1700408 35B1700412 35B1700499 35B1700525
Z-0344-2022Puritan Bennett 980 Series Ventilator, 980U3ESDIUU; GTIN/UDI - 10884521201545 Serial Numbers: 35B1700548 35B1700551 35B1700560 35B1700572 35B1700577 35B1700603 35B1700606 35B1700615
Z-0345-2022Puritan Bennett 980 Series Ventilator,980X1ENAIQC; GTIN/UDI - 10884521171787 Serial Numbers: 35B1703376
Z-0346-2022Puritan Bennett 980 Series Ventilator, 980X1ENDIPC; GTIN/UDI - 10884521172302 Serial Numbers: 35B1700447 35B1700405
Z-0347-2022Puritan Bennett 980 Series Ventilator, 980X1ENDIUU; GTIN/UDI - 10884521171541 Serial Numbers: 35B1700300 35B1700306 35B1700307 35B1700362 35B1700372 35B1700384 35B1700387 35B1700388 35B1700396 35B1700397 35B1700403 35B1700413 35B1700416 35B1700418 35B1700426 35B1700431 35B1700434 35B1700440 35B1700445 35B1700451 35B1700452 35B1700453 35B1700459 35B1700461 35B1700464 35B1700468 35B1700472 35B1700477 35B1700478 35B1700479 35B1700480 35B1700484 35B1700485 35B1700494 35B1700495 35B1700496 35B1700501 35B1700502 35B1700503 35B1700504 35B1700534 35B1700574 35B1700579 35B1700604 35B1700609 35B1700638 35B1700655 35B1700664 35B1700816 35B1700919 35B1700994 35B1701001 35B1701418 35B1701698 35B1702832 35B1703438 35B1800033 35B1800721 35B1800811
Z-0348-2022Puritan Bennett 980 Series Ventilator, 980X1ENNISB; GTIN/UDI - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608
Z-0349-2022Puritan Bennett 980 Series Ventilator, 980X1JADIJJ; GTIN/UDI - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026
Z-0350-2022Puritan Bennett 980 Series Ventilator, 980X1PLDIPC; GTIN/UDI - 10884521171619 Serial Numbers: 35B1700425 35B1700438 35B1700458 35B1700460 35B1700656 35B1700659 35B1700660
Z-0351-2022Puritan Bennett 980 Series Ventilator, 980X2ESDIEC; GTIN/UDI - 10884521174177 Serial Numbers: 35B1700627 35B1700628 35B1700629 35B1700630 35B1700631 35B1700632
Z-0352-2022Puritan Bennett 980 Series Ventilator, 980X3ENDIUU; GTIN/UDI - 10884521172524 Serial Numbers: 35B1700308 35B1700311 35B1700361 35B1700363 35B1700364 35B1700366 35B1700368 35B1700369 35B1700370 35B1700371 35B1700373 35B1700375 35B1700376 35B1700377 35B1700378 35B1700379 35B1700380 35B1700382 35B1700383 35B1700385 35B1700386 35B1700389 35B1700390 35B1700391 35B1700392 35B1700394 35B1700395 35B1700398 35B1700400 35B1700401 35B1700402 35B1700404 35B1700410 35B1700414 35B1700415 35B1700417 35B1700421 35B1700422 35B1700423 35B1700424 35B1700433 35B1700441 35B1700444 35B1700446 35B1700448 35B1700450 35B1700454 35B1700455 35B1700463 35B1700466 35B1700491 35B1700497 35B1700498 35B1700500 35B1700506 35B1700515 35B1700521 35B1700523 35B1700524 35B1700528 35B1700532 35B1700535 35B1700550 35B1700556 35B1700571 35B1700607 35B1700620 35B1700666 35B1700989 35B1701004 35B1701015 35B1701417 35B1701419 35B1702698 35B1702873 35B1703371 35B1703383 35B1703421 35B1800480 35B1800511 35B1800522 35B1800531
Z-0353-2022Puritan Bennett 980 Series Ventilator, 980X3JADIJJ; GTIN/UDI - 10884521172531 Serial Numbers: 35B1700393 35B1700419 35B1700420 35B1700427 35B1700428 35B1700429 35B1700540 35B1700564 35B1700568 35B1700573 35B1800002
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Verify your ventilator's serial number to see if it falls within the range 35B1700627 to 35B1700632.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Nov 4, 202112. FDA classified it Class I: Dec 9, 202123. Published in FDA’s Enforcement Report: Dec 15, 202134. FDA terminated the recall: Jul 9, 2024420212024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the ventilator immediately?

The recall does not require immediate discontinuation; affected units should be checked for inoperability.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0351-2022 (November 4, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0351-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA