Gyrus ACMI, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1182-2019)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2019.
Data Source: FDA.
Product Description:
Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS
Product Classification:
Class II
Date Initiated: March 8, 2019
Date Posted: April 24, 2019
Recall Number: Z-1182-2019
Event ID: 82451
Reason for Recall:
Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when used with Diego Elite blades
Status: Terminated
Product Quantity: 247
Code Information:
All lot numbers
Distribution Pattern:
Nationwide Foreign: Germany,Japan, Singapore
Voluntary or Mandated:
Voluntary: Firm initiated