Covidien Llc: Medical Device Recall in 2021 - (Recall #: Z-0342-2022)

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, 980U1ENASAA

Product Classification:

Class I

Date Initiated: November 4, 2021

Date Posted: December 15, 2021

Recall Number: Z-0342-2022

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 - 10884521201385 Serial Numbers: 35B1700252 35B1700365 35B1700399 35B1700407 35B1700489 35B1700505 35B1700513 35B1700555 35B1700557 35B1700562 35B1700563 35B1700565 35B1700566 35B1700605 35B1700612 35B1700634 35B1700651 35B1700662 35B1700663

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated