CLASS I Device recall · Reported 15 Dec 2021 · FDA Enforcement Report

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU recalled by Covidien

Covidien is recalling Puritan Bennett 980 Series Ventilator, 980X1ENDIUU, distributed nationwide in the US. The recall was initiated on 4 Nov 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesGTIN/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

Quantity recalled278 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0347-2022
FDA event ID: 88987
Recalling firm: Covidien, Mansfield, MA
Classification: Class I
Status: Terminated
Recall initiated: 4 Nov 2021
FDA classified: 9 Dec 2021
Reported: 15 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: CPAP & Ventilators

Timeline

4 Nov 2021	Recall initiated by company
9 Dec 2021	Classified by FDA	+35 days
15 Dec 2021	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

Product as listed by the FDA

Puritan Bennett 980 Series Ventilator, 980X1ENDIUU

Where it was distributed

Worldwide distribution - US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

Which lots are affected?

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

Where was it sold?

Worldwide distribution - US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

15 other products · FDA event 88987

This product is part of a recall event; the main page for the event is Puritan Bennett 980 Series Ventilator, 980X2ESDIEC recalled by Covidien.

Reported	Class	Recall	Company	Reason	Where
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X2ESDIEC recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980U1ESDIUC recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980U1ENASAA recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X3ENDIUU recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X1ENNISB recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980S3ENDICU recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980A3ENNISB recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X1ENDIPC recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980S1ENDICU recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980A1ENNISB recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X1JADIJJ recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator,980X1ENAIQC recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980U3ESDIUU recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X3JADIJJ recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X1PLDIPC recalled by Covidien	Covidien	Other	Nationwide

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Other CPAP & Ventilators recalls

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Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled	Medline Industries	Device Malfunction	Nationwide
26 Aug 2026Device	CLASS II	Getinge Y Sensor Module, Servo-u, Servo recalled	Maquet Critical Care AB	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics	BioFire Diagnostics	Other	Nationwide
5 Aug 2026Device	CLASS I	Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled	ResMed	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Breathing circuit set, coaxial recalled by Hamilton Medical AG	Hamilton Medical	Device Malfunction	Nationwide