The Recall Desk
SevereFDA (Devices)·Z-0350-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect

Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device 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: FDA Class I classification mandates a minimum severity level of 4 (Severe). No reported illnesses, injuries, or deaths prevent a higher rating. The defect involves a critical care device where inoperability during use could pose a serious risk.

Plain-English summary

Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X1PLDIPC) due to a manufacturing assembly defect. The device contains a capacitor that may have been assembled incorrectly, which could cause the ventilator to become inoperable during use.

The recalled units were distributed worldwide, including throughout the United States. Affected serial numbers include: 35B1700425, 35B1700438, 35B1700458, 35B1700460, 35B1700656, 35B1700659, and 35B1700660.

This is a Class I recall. Healthcare facilities and providers using affected ventilators should identify units by serial number and follow FDA and manufacturer guidance for corrective action.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
Manufacturer
Covidien Llc
Category
Medical Device — Critical Care Equipment
Hazard
  • assembly-defect
  • device-failure

Distribution

Distributed nationwide across the United States.

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