Device recall

Z-2254-2020: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit, Part…

FDA device recall · Class II · Covidien Llc

Key facts

Recall number (Z-number) Z-2254-2020
Recall event 85689
Product Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
Product code GCI
Recalling firm Covidien Llc
Recall class Class II
Status Open, Classified
510(k) numbers K912097
FEI number 1282497

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)