The Recall Desk
SevereFDA (Devices)·Z-0340-2022·Announced 2021-12-15

Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect

Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability 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: This is an FDA Class I recall, which establishes a minimum severity score of Severe (4). Although no illnesses or injuries have been reported, the manufacturing defect may cause device inoperability during use.

Plain-English summary

Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980S1ENDICU) due to a manufacturing assembly error where a capacitor may have been incorrectly installed. This defect may cause the ventilator to become inoperable during use.

The affected units have been distributed worldwide and throughout the United States. The recalled serial numbers are: 35B1700409, 35B1700443, 35B1700457, 35B1700462, 35B1700473, 35B1700476, 35B1700483, 35B1700487, 35B1700490, 35B1700511, 35B1700552, 35B1700567, 35B1700569, 35B1700570.

Anyone with one of these ventilators should check the serial number to determine if their device is affected.

The recalled product

Product
Puritan Bennett 980 Series Ventilator, 980S1ENDICU
Manufacturer
Covidien Llc
Category
Medical Device — Ventilator
Hazard
  • manufacturing-defect
  • device-inoperability

Distribution

Distributed nationwide across the United States.

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