Z-1845-2016Class II

EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source...

Name: Z-1845-2016 EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source...
Creator: Olympus Corporation of the Americas
Published: 2016-03-15
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2016-03-15 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy... on 2016-03-15. FDA classified it as Class II and gives the reason as "New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534)...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1845-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-15
Posted: 2016-05-31
Terminated: 2018-02-06
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.
FDA root cause: Under Investigation by firm
Action: Olympus notified customers on 03/14/2016 via an Urgent Safety Notification letter that referenced discontinuation of previously distributed copies of the TJF-160F/VF Reprocessing Manual. Customers were asked to inspect their inventory and discard any existing inventory of TJF-160F/VF Reprocessing Manuals. They were asked to update their information with the enclosed TJF-160F/VF Reprocessing Manual, which contains new brushing and flushing steps for the TJF-160F/VF elevator mechanisms and the forceps elevator recesses. Instuctions for cleaning and a new cleaning brush (used for cleaning the device) was included with the notification. Customers were asked to ensure all reprocessing personnel are completely knowledgeable and throughly training on the new reprocessing instructions in the new Reprocessing Manual.
Distribution: Nationwide:
Product codes and lots: Models: TJF-160F and TJF-160VF, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1845-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1845-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code FDT

K024033Class IIXtjf-160Af DuodenovideoscopeOlympus Optical Co., Ltd. / cleared 2002-12-20

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)