FDA Device recall Z-1292-2021
Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipme…
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipme… by Olympus, citing olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the dista….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1292-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-28 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Olympus |
| Distribution | US |
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
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).
Identifiers
| code_info | Model: TJF-Q190V |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1292-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.