Device recall

Z-1275-2022: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper…

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-1275-2022
Recall event 90232
Product EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Product code FDS
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
FEI number 2429304

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)