Device recall

Z-1264-2020: Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection…

FDA device recall · Class II · COVIDIEN LLC

Key facts

Recall number (Z-number) Z-1264-2020
Recall event 84811
Product Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Product code GDW
Recalling firm COVIDIEN LLC
Recall class Class II
Status Terminated
Termination date Jul 29, 2022
510(k) numbers K111825
FEI number 1282497

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)