The Recall Desk
SevereFDA (Devices)·Z-0342-2022·Announced 2021-12-15

Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.

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: FDA Class I classification mandates a minimum severity of Severe. The manufacturing defect in a critical medical device that may become inoperable during use justifies this classification.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class I recall for the Puritan Bennett 980 Series Ventilator, model 980U1ENASAA, manufactured by Covidien Llc. A total of 278 units are subject to this recall.

The recall is due to a manufacturing assembly error. A capacitor within the ventilator was assembled incorrectly. This error may cause the device to become inoperable during use.

The affected units have been distributed worldwide, including throughout the United States. The affected units can be identified by their serial numbers, which are detailed in the official recall notice.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980U1ENASAA
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory Equipment
Hazard
  • assembly-error
  • capacitor-defect
  • inoperability

Distribution

Distributed nationwide across the United States.

Related recalls

Same category