EVIS EXERA II Gastrointestinal Videoscope-indicated for use within… — Class II medical device recall Z-1275-2022
Ongoing recall by Olympus Corporation of the Americas, reported 2022-06-29, distributed nationwide. Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacin
| Recall number | Z-1275-2022 |
|---|---|
| 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 | 2022-04-22 |
| Classified | 2022-06-21 |
| Reported by FDA | 2022-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 04953170305276 |
| Serial numbers | 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773, 2962545 |
| Model numbers | GIF-HQ190 |
Product
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
Reason for recall
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications
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-1275-2022. 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.