Olympus Corporation of the Americas: Medical Device Recall in 2016 - (Recall #: Z-0757-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

Product Classification:

Class II

Date Initiated: January 8, 2016

Date Posted: February 10, 2016

Recall Number: Z-0757-2016

Event ID: 73059

Reason for Recall:

Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.

Status: Terminated

Product Quantity: 4436

Code Information:

all codes

Distribution Pattern:

US Nationwide Distribution except PR

Voluntary or Mandated:

Voluntary: Firm initiated