Device recall

Z-0829-2012: Olympus Endoscopic Electrosurgical Unit working elements, model numbers…

FDA device recall · Class II · Olympus America Inc.

Key facts

Recall number (Z-number) Z-0829-2012
Recall event 60772
Product Olympus Endoscopic Electrosurgical Unit working elements, model numbers WA22366A, and WA22367A. Working element for cutting, coagulation, and vaporization in conductive irrigation fluid or conductive distension medium in the Saline mode.
Product code KNS
Recalling firm Olympus America Inc.
Recall class Class II
Status Terminated
Termination date Dec 21, 2013
510(k) numbers K030194
FEI number 2429304

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)