Olympus Corporation of the Americas EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
All serial numbers. UDI: 04953170339967
Products Sold
All serial numbers. UDI: 04953170339967
Olympus Corporation of the Americas is recalling EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V due to Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid in. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 Cynthia.Ow@Olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026