EVIS EXERA III Duodenovideoscope (Olympus) – Reprocessing Update (2025)
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
Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model/Catalog Number: TJF-Q190V, UDI: 04953170405563 / 04953170452024, Serial Numbers: All
Products Sold
Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;
Olympus Corporation of the Americas is recalling Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: T due to Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF du. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
Recommended Action
Per FDA guidance
On October 14, 2025 URGENT: MEDICAL DEVICE CORRECTION letters were sent to customers. Actions to be taken: Carefulle read the notification and ensure that all personnel are completely knowledgeable and thoroughly trained on the content of the letter. Complete the required training provided in the letter. Keep a copy of the notification with the operation manual. It is recommended to receive on-site TJF duodenoscope reprocessing training at your facility. If you have further distributed this product, identify and forward them this notification.
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