Covidien, LP: Medical Device Recall in 2020 - (Recall #: Z-0003-2021)

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 30 mm - 3.5 mm, Item Code 030452 - 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-0003-2021

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: T0C085X T8B048X T8K049X T8L087X T9J072X T7H002X T8B049X T8K095X T9G027X T9J099X T7L026X T8E063X T8L084X T9H043X T9L073X T7L027X T8E064X T8L085X T9H115X T9M016X T8B014X T8E075X T8L086X T9H116X T9M111X T8B015X T8F074X

Distribution Pattern:

Worldwide distribution - US Nationwide and Global Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated