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

Puritan Bennett 980 Series Ventilator, 980X1ENDIPC recalled by Covidien

Covidien is recalling Puritan Bennett 980 Series Ventilator, 980X1ENDIPC, 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 - 10884521172302 Serial Numbers: 35B1700447 35B1700405

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-0346-2022
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, 980X1ENDIPC

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 - 10884521172302 Serial Numbers: 35B1700447 35B1700405

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, 980S1ENDICU recalled by Covidien	Covidien	Other	Nationwide
15 Dec 2021	CLASS I	Puritan Bennett 980 Series Ventilator, 980X1ENDIUU 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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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