Olympus America Inc.: Medical Device Recall in 2015 - (Recall #: Z-2807-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Product Classification:

Class II

Date Initiated: March 26, 2015

Date Posted: September 30, 2015

Recall Number: Z-2807-2015

Event ID: 70858

Reason for Recall:

New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope ("TJF-Q180V"), consisting of revised manual cleaning and high level disinfection procedures.

Status: Terminated

Product Quantity: 6109

Code Information:

Model: TJF-Q180V, all sold units

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.

Voluntary or Mandated:

Voluntary: Firm initiated