Z-0757-2016Class II

Olympus TJF-Q180V flexible gastrointestinal Duodenoscope

Name: Z-0757-2016 Olympus TJF-Q180V flexible gastrointestinal Duodenoscope
Creator: Olympus Corporation of the Americas
Published: 2016-01-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2016-01-08 / Terminated / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light... on 2016-01-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0757-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-08
Posted: 2016-02-04
Terminated: 2017-01-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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 code: FDT Duodenoscope And Accessories, Flexible/Rigid
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.
Root cause tag: design
FDA root cause: No Marketing Application
Action: Olympus America Inc. sent an Urgent Notification letter dated January 15, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory for the affected product, Olympus will contact facilities to make arrangements for return of the TJF-Q180V duodenoscope(s) for the elevator mechanism replacement. For questions call (484) 896-5688.
Quantity in commerce: 4436
Distribution: US Nationwide Distribution except PR
Product codes and lots: all codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0757-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0757-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-04

Product code FDT

K080403Class IIXtjf Type Q160vf1Olympus Medical Systems Corporation / cleared 2008-05-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)