The Recall Desk
SevereFDA (Devices)·Z-0351-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk

Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.

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 requires a minimum severity score of Severe. The device failure mode—potential inoperability during clinical use of a critical life-support device—poses direct risk to patient safety.

Plain-English summary

Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators (model 980X2ESDIEC) due to a manufacturing assembly error involving a capacitor. The capacitor was assembled incorrectly during manufacturing, which may cause the ventilator to become inoperable during use.

The affected units have serial numbers 35B1700627, 35B1700628, 35B1700629, 35B1700630, 35B1700631, and 35B1700632. These devices were distributed worldwide and throughout the United States.

If you are using an affected ventilator, verify the serial number against the list provided. If your device matches, contact Covidien immediately to arrange replacement or repair. Healthcare providers should discontinue use of affected units and follow up with Covidien on resolution options.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
Manufacturer
Covidien Llc
Category
Medical Device — Respiratory Equipment
Hazard
  • device-failure
  • manufacturing-defect

Distribution

Distributed nationwide across the United States.

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