Device recall

Z-0636-2018: Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal…

FDA device recall · Class II · Covidien LLC

Key facts

Recall number (Z-number) Z-0636-2018
Recall event 79169
Product Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Product code GDW
Recalling firm Covidien LLC
Recall class Class II
Status Terminated
Termination date Jun 28, 2019
510(k) numbers K111825
FEI number 1219930

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)