Duodenoscope and accessories — Class II medical device recall Z-1292-2021
Terminated recall by Olympus Corporation of the Americas, reported 2021-03-31, distributed nationwide. Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the force
| Recall number | Z-1292-2021 |
|---|---|
| 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 | 2021-01-28 |
| Classified | 2021-03-22 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2024-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, JP |
| Model numbers | TJF-Q190V |
Product
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Reason for recall
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
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-1292-2021. 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.