Z-0498-2025 Class II Ongoing
FDA device recall Z-0498-2025 was initiated by Olympus Corporation Of The Americas on Sep 18, 2024 and is designated Class II. Reason for recall: To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a… The recall status is ongoing. Affected quantity: 1749 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2024
- Initiation Date
- Sep 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1749 units
Product Description
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Reason for Recall
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Distribution Pattern
Domestic: US Nationwide Distribution.
Code Information
Model: GIF-1TH190, UDI-DI: 04953170343360, Serial #: Less than 2446103.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0498-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026