Device recall

Z-0874-2026: Olympus OER-Mini

FDA device recall · Class II · Aizu Olympus Co., Ltd.

Key facts

Recall number (Z-number) Z-0874-2026
Recall event 97849
Product Olympus OER-Mini
Product code FEB
Recalling firm Aizu Olympus Co., Ltd.
Recall class Class II
Status Open, Classified
510(k) numbers K120357
FEI number 3002964398

At a glance

  • 1–9 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)