Olympus Corporation of the Americas 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model: TJF-Q190V
Products Sold
Model: TJF-Q190V
Olympus Corporation of the Americas is recalling Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system cent due to Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duod. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
On 2/5/2021, Olympus issued Urgent Device Correction notices to customers via letter informing them Olympus has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the single-use distal cover, MAJ-2315, after withdrawing the TJF-Q190V duodenoscope from the patient. In the reported complaints, the user facilities have reported mucosal injuries in the esophagus, stomach, and duodenum. Olympus is thoroughly investigating the root cause or causes of these reported events. This notice included information that may reduce the potential occurrence of similar incidents.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026