The Recall Desk
SevereFDA (Devices)·Z-0349-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator recalled for assembly defect

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

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 is an FDA Class I recall, which requires a minimum severity score of 4 per the rubric. A capacitor assembly defect causing ventilator inoperability during use poses a serious patient safety risk, as ventilators are life-critical medical equipment. No deaths or injuries have been reported in the source text.

Plain-English summary

The Puritan Bennett 980 Series Ventilator, model 980X1JADIJJ, manufactured by Covidien LLC, is being recalled by the FDA. The recall affects 278 units that were distributed worldwide, including to medical facilities throughout the United States.

A manufacturing assembly error in the ventilator's capacitor may cause the device to become inoperable during use. Ventilators are critical life-support equipment, and device failure during patient use poses a serious risk to patient safety.

If you have one of the affected ventilators, stop using it immediately and contact Covidien LLC. The FDA recall notice identifies the specific serial numbers and product codes for affected units. Healthcare facilities should review their equipment inventories and discontinue use of any matching ventilators.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory Equipment
Hazard
  • device-inoperability
  • assembly-defect

Distribution

Distributed nationwide across the United States.

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