Covidien Llc: Medical Device Recall in 2021 - (Recall #: Z-0349-2022)

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, 980X1JADIJJ

Product Classification:

Class I

Date Initiated: November 4, 2021

Date Posted: December 15, 2021

Recall Number: Z-0349-2022

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 - 10884521171558 Serial Numbers: 35B1700309 35B1700374 35B1700411 35B1700432 35B1700435 35B1700436 35B1700437 35B1700439 35B1700470 35B1700475 35B1700482 35B1700486 35B1700488 35B1700492 35B1700493 35B1700512 35B1700516 35B1700517 35B1700518 35B1700519 35B1700522 35B1700529 35B1700531 35B1700538 35B1700544 35B1700545 35B1700546 35B1700547 35B1700549 35B1700575 35B1700578 35B1700610 35B1800026

Distribution Pattern:

Worldwide distribution - US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated