Covidien LLC: Medical Device Recall in 2019 - (Recall #: Z-1825-2019)

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 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

Product Classification:

Class II

Date Initiated: May 17, 2019

Date Posted: June 26, 2019

Recall Number: Z-1825-2019

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:

lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

Distribution Pattern:

Nationwide domestic distribution, worldwide foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated