Z-2807-2015Class II

EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an...

Name: Z-2807-2015 EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an...
Creator: Olympus America Inc.
Published: 2015-03-26
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2015-03-26 / Terminated / root cause: labeling and UDI

FDA source

Olympus America Inc. began a recall of EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source... on 2015-03-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2807-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-26
Posted: 2015-09-22
Terminated: 2017-02-01
Recalling firm: OLYMPUS Corporation of the Americas
Product: 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 code: FDT Duodenoscope And Accessories, Flexible/Rigid
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at [email protected].
Quantity in commerce: 6109
Distribution: Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
Product codes and lots: Model: TJF-Q180V, all sold units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2807-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2807-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-22

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)