Olympus GIF-H180J Gastrointestinal Videoscope — Class II medical device recall Z-1008-2019
Terminated recall by Olympus Corporation of the Americas, reported 2019-03-20, distributed nationwide. The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonco
| Recall number | Z-1008-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2018-12-17 |
| Classified | 2019-03-12 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-11-18 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| Serial numbers | 2418319 |
Product
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
Reason for recall
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
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-1008-2019. 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.