The Recall Desk
HighFDA (Devices)·Z-0345-2022·Announced 2021-12-15

Puritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error

Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class I recall; however, no illnesses or injuries have been reported and the hazard is theoretical (device "may" become inoperable). A capacitor defect affecting critical life-support equipment represents significant potential harm despite the absence of actual reported patient harm.

Plain-English summary

Covidien Llc is recalling the Puritan Bennett 980 Series Ventilator, model 980X1ENAIQC, due to a manufacturing assembly error. A capacitor was assembled incorrectly, which may cause the ventilator to become inoperable during use.

The recall affects 278 units distributed worldwide, including throughout the United States. Affected devices can be identified by serial number 35B1703376 and GTIN/UDI 10884521171787.

This is a Class I FDA recall, indicating a serious health hazard. The recalled ventilators are used as life-support equipment in healthcare settings.

The recalled product

Product
Puritan Bennett 980 Series Ventilator,980X1ENAIQC
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory / Ventilator
Hazard
  • device-inoperability
  • 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 (1)

  • GTIN/UDI - 10884521171787 Serial Numbers: 35B1703376

Distribution

Distributed nationwide across the United States.

Related recalls

Same category