Covidien, LP: Medical Device Recall in 2020 - (Recall #: Z-0004-2021)

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 Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - 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-0004-2021

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: T7F017X T7J023X T7L032X T7L034X T8L100X T7F025X T7J024X T7L033X T7L035X T9F138X T7F026X T7K020X

Distribution Pattern:

Worldwide distribution - US Nationwide and Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated