The Recall Desk
SevereFDA (Devices)·Z-0339-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect

Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is classified as Severe because the FDA designated it as a Class I recall, indicating a reasonable probability of serious adverse health consequences. No deaths or injuries have been reported to date; the severity is based on the potential for device malfunction during patient use.

Plain-English summary

Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator (model 980A3ENNISB) due to a manufacturing defect. A capacitor within the ventilator was assembled incorrectly during manufacturing, which may cause the device to become inoperable during use.

Approximately 278 units have been distributed worldwide, including throughout the United States. Affected devices carry serial numbers 35B1700246, 35B1700543, and 35B1700887. The FDA classified this as a Class I recall due to the potential for device failure during use.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980A3ENNISB
Manufacturer
Covidien Llc
Category
Medical Device — Ventilator / Respiratory Equipment
Hazard
  • device-malfunction
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • GTIN/UDI - 10884521201910 Serial Numbers: 35B1700246
  • 35B1700543
  • 35B1700887

Distribution

Distributed nationwide across the United States.

Related recalls

Same category