CLASS I Device recall · Reported 15 Dec 2021 · FDA Enforcement Report
Puritan Bennett 980 Series Ventilator, 980X1ENNISB recalled by Covidien
Covidien is recalling Puritan Bennett 980 Series Ventilator, 980X1ENNISB, 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
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-0348-2022
- 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, 980X1ENNISB
Where it was distributed
Worldwide distribution - US Nationwide.
Questions about this recall
Is Puritan Bennett 980 Series Ventilator, 980X1ENNISB recalled?
Yes. Covidien recalled Puritan Bennett 980 Series Ventilator, 980X1ENNISB on 4 Nov 2021. The recall is Class I and its status is Terminated. Recall number Z-0348-2022.
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 - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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