Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190… — Class II medical device recall Z-0498-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-11-27, distributed nationwide. To better define the drying procedures described in the IFU to improve the instructions for easier understandi
| Recall number | Z-0498-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2024-09-18 |
| Classified | 2024-11-20 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 1,749 units |
| UPC / GTIN / UDI-DI | 04953170343360 |
| Model numbers | GIF-1TH190 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0498-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.