Olympus Gastrointestinal Videoscope — Class II medical device recall Z-0181-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2024-10-30, distributed nationwide. It was discovered during device performance testing that the CCD imaging sensors were programmed with the inco
| Recall number | Z-0181-2025 |
|---|---|
| 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 | 2024-08-21 |
| Classified | 2024-10-23 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,407 units |
| UPC / GTIN / UDI-DI | 04953170420191 |
| Model numbers | GIF-1100 |
Product
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
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.
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-0181-2025. 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.