EVIS EXERA III Gastrointestinal Videoscope — Class II medical device recall Z-0288-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2023-11-15, distributed nationwide. Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for
| Recall number | Z-0288-2024 |
|---|---|
| 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 | 2023-10-02 |
| Classified | 2023-11-09 |
| Reported by FDA | 2023-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,687 units |
| UPC / GTIN / UDI-DI | 04953170343360 |
| Model numbers | GIF-1TH190 |
Product
EVIS EXERA III Gastrointestinal Videoscope
Reason for recall
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
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-0288-2024. 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.