Olympus Corporation of the Americas: Device Recall

Recall #Z-0181-2025 · 08/21/2024

Class II: Risk

Recall Details

Recall Number: Z-0181-2025
Classification: Class II
Product Type: Device
Recalling Firm: Olympus Corporation of the Americas
Status: Ongoing
Date Initiated: 08/21/2024
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1407 units

Reason for Recall

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

Product Description

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

Distribution Pattern

US Nationwide distribution.

Other Recalls by Olympus Corporation of the Americas

Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.