Device recall

Z-1004-2024: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate…

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

Key facts

Recall number (Z-number) Z-1004-2024
Recall event 93785
Product Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
Product code ETD
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
510(k) numbers K932166
FEI number 2429304

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)