Olympus JF-160F Duodenoscopes Recalled for New Reprocessing Procedures
Olympus Corporation of the Americas is recalling 68 JF-160F duodenoscopes nationwide to implement validated new reprocessing procedures.
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 methods 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 68 units of the Olympus JF-160F duodenoscope (Model Number JF-160F) nationwide. The recall is being conducted to issue validated, new reprocessing procedures for the devices.
The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning, and manual disinfection. This update is intended to ensure the devices are properly reprocessed according to the new validated standards.
Healthcare facilities and users of these specific duodenoscopes should stop using the devices and contact Olympus Corporation of the Americas for instructions on implementing the new reprocessing procedures.
The recalled product
- Product
- Olympus JF-160F duodenoscopes (Model NumberJF-160F)
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopes
- Affected units
- 68
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 (1)
- All
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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