Covidien Llc: Medical Device Recall in 2021 - (Recall #: Z-0348-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Puritan Bennett 980 Series Ventilator, 980X1ENNISB

Product Classification:

Class I

Date Initiated: November 4, 2021

Date Posted: December 15, 2021

Recall Number: Z-0348-2022

Event ID: 88987

Reason for Recall:

Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.

Status: Terminated

Product Quantity: 278 total

Code Information:

GTIN/UDI - 10884521171749 Serial Numbers: 35B1700430 35B1700442 35B1700456 35B1700510 35B1700514 35B1700520 35B1700553 35B1700554 35B1700559 35B1700561 35B1700608

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated