EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V — Class II medical device recall Z-2807-2015
Terminated recall by Olympus America Inc., reported 2015-09-30, distributed nationwide. New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"
| Recall number | Z-2807-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus America Inc., Center Valley, PA, United States |
| Recall initiated | 2015-03-26 |
| Classified | 2015-09-22 |
| Reported by FDA | 2015-09-30 |
| Terminated | 2017-02-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, MX |
| Quantity | 6,109 |
| Model numbers | TJF-Q180V |
Product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Reason for recall
New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.
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-2807-2015. 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.