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U.S. Department of Health and Human Services

Class 2 Device Recall EVIS EXERA III Duodenovideoscope

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 Class 2 Device Recall EVIS EXERA III Duodenovideoscopesee related information
Date Initiated by FirmOctober 14, 2025
Date PostedNovember 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0579-2026
Recall Event ID 97681
510(K)NumberK251867 
Product Classification Duodenoscope and accessories, flexible/rigid - Product Code FDT
ProductBrand 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.
Code Information Model/Catalog Number: TJF-Q190V; UDI: 04953170405563 / 04953170452024; Serial Numbers: All;
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce7023 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FDT
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