Covidien LLC: Medical Device Recall in 2019 - (Recall #: Z-1827-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

EGIA 45 ARTICULATING XTRA THICK SULU, Item Code EGIA45AXT

Product Classification:

Class II

Date Initiated: May 17, 2019

Date Posted: June 26, 2019

Recall Number: Z-1827-2019

Event ID: 82950

Reason for Recall:

The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.

Status: Ongoing

Product Quantity: 3,113,280

Code Information:

N6B0080KX N6C0975KX

Distribution Pattern:

Nationwide domestic distribution, worldwide foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated