Covidien, LP: Medical Device Recall in 2020 - (Recall #: Z-0001-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Product Classification:

Class II

Date Initiated: August 12, 2020

Date Posted: October 7, 2020

Recall Number: Z-0001-2021

Event ID: 86214

Reason for Recall:

The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.

Status: Ongoing

Product Quantity: 900,007 total

Code Information:

Lot Numbers: T0A108X T7H003X T8D008X T8K108X T9G060X T0E051X T7L023X T8H047X T8M079X T7G003X T8D007X T8K047X T9F132X

Distribution Pattern:

Worldwide distribution - US Nationwide and Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated