Olympus EVIS EXERA III Duodenovideoscope — Class II medical device recall Z-1911-2025
Ongoing recall by Olympus Corporation of the Americas, reported 2025-06-11, distributed nationwide. Recent post-market surveillance data suggests a possible association of higher microbial contamination levels
| Recall number | Z-1911-2025 |
|---|---|
| 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 | 2025-05-05 |
| Classified | 2025-06-05 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BO, BR, CA, CH, CL, CO, CR, DE, DK, DO, DZ, EE, EG, ES, FI, FR, GH, GT, HK, HN, HR, IN, IQ, IS, IT, JO, JP, KE, KR, KW, KY, LB, LT, LU, LV, MA, MT, MX, MY, NG, NI, NL, NO, NZ, OM, PA, PE, PL, PT, PY, QA, RU, SA, SE, SG, SV, TH, TN, TR, UA, UY, VN, ZA |
| Quantity | 12,195 units |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 04953170405563 |
| Model numbers | TJF-Q190V |
Product
Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Reason for recall
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
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-1911-2025. 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.