Olympus Recalls Duodenoscopes for New Reprocessing Instructions
Olympus Corporation of the Americas is recalling TJF-160F and TJF-160VF duodenoscopes to provide new reprocessing instructions and a cleaning brush.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a procedural update to reprocessing instructions without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Olympus Corporation of the Americas is recalling the EVIS EXERA Duodenovideoscope, models TJF-160F and TJF-160VF, all serial numbers. The recall is nationwide and involves the provision of new reprocessing instructions for the devices.
The recall is being conducted to implement revised manual cleaning and high-level disinfection procedures. A new cleaning brush, model MAJ-1534, is enclosed with the notification to support these updated procedures.
These devices are used with an Olympus video system center, light source, documentation equipment monitors, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Users should implement the new reprocessing instructions and utilize the provided cleaning brush as directed in the notification.
The recalled product
- Product
- EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Models: TJF-160F and TJF-160VF
- all serial numbers
Distribution
Distributed nationwide across the United States.
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