Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product… — Class II medical device recall Z-0757-2016
Terminated recall by Olympus Corporation of the Americas, reported 2016-02-10, distributed nationwide. Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in orde
| Recall number | Z-0757-2016 |
|---|---|
| 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 | 2016-01-08 |
| Classified | 2016-02-04 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2017-01-09 |
| Distributed | Nationwide (US) |
| Quantity | 4,436 |
Product
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Reason for recall
Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.
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-0757-2016. 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.