Z-0379-2022Class II

EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V

Name: Z-0379-2022 EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Creator: Olympus Corporation of the Americas
Published: 2021-11-02
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-11-02 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V on 2021-11-02. FDA classified it as Class II and gives the reason as "Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0379-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-02
Posted: 2021-12-10
Recalling firm: OLYMPUS Corporation of the Americas
Product: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.
FDA root cause: Under Investigation by firm
Action: Olympus issued Urgent Medical Device Corrective Action on 11/02/21. Letter states reason for correction, health risk and action to take: 1. Consider transitioning from TJF-Q180V to a next generation duodenoscope through the Olympus incentive program. 2. Increase preventative maintenance frequency from annual to 6 months. 3. Evaluate existing duodenoscopes: https://medical.olympusamerica.com/TJFQ180VChecklist 4. The Technical Assistance Center (TAC) can assist you in answering questions on the TJF-Q180V inspection steps. 1-800-848-9024, option 1. 5. Use in-service training, the Olympus Video Guide, e-learning and on demand library to support staff training. ***UPDATE: Olympus issued an Urgent Medical Device Corrective Action UPDATED INFORMATION on 1/17/22. This is an update to the 11/2/21 previously provided supplemental material for inspection. In alignment with FDA Safety Communication dated August 29, 2019, and to further expedite transition to newer-generation duodenoscopes, Olympus America will soon begin offering customers with the older generation TJF-Q180V2 scopes a direct, no-cost 1 for 1 replacement with the state-of-the-art TJF-Q190V. Your Olympus sales representative will contact you regarding this program in the near future. In the interim, please continue to utilize the TJF-Q180V Inspection Checklist that Olympus recently sent. Olympus America will also be increasing the frequency of proactive inspection from once every twelve (12) months to once every six (6) months. To help minimize any potential patient impact regarding access to critical, life-saving ERCP procedures, loaners are available to mitigate disruption to healthcare facilities who need to return their duodenoscope(s) to Olympus for repair. For any questions or concerns, please do not hesitate to contact me directly at [email protected].
Quantity in commerce: 14,447 units
Distribution: US Nationwide distribution.
Product codes and lots: All serial numbers. UDI: 04953170339967

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0379-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0379-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-22	2021-12-10

Product code FDT

K143153Class IIEvis Exera II Duodenovideoscope Olympus Tjf Type Q180vOlympus Medical Systems Corp. / cleared 2016-01-15

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)