medical Class II Updated 2021-03-31

Olympus Corporation of the Americas recalls Duodenoscope and accessories, flexible/rigid - Product Usage

Recalled 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.


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model: TJF-Q190V
View official government recall

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