Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0644-2024)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2024.
Data Source: FDA.
Product Description:
OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities, including female reproductive organs.
Product Classification:
Class II
Date Initiated: November 20, 2023
Date Posted: January 17, 2024
Recall Number: Z-0644-2024
Event ID: 93575
Reason for Recall:
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Status: Ongoing
Product Quantity: 1403 units US
Code Information:
UDI-DI: 04953170310355 All Serial Numbers
Distribution Pattern:
Nationwide
Voluntary or Mandated:
Voluntary: Firm initiated