Olympus JF-140F Duodenoscopes Recalled for New Reprocessing Procedures
Olympus is recalling 994 JF-140F duodenoscopes nationwide to implement new reprocessing procedures following reported patient infections.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly mentions 'reported patient infections,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or hospitalization-level severity, warranting a score of 4.
Plain-English summary
Olympus Corporation of the Americas is recalling 994 units of the JF-140F duodenoscope. The recall is being conducted nationwide to issue validated, new reprocessing procedures for the devices.
This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning, and manual disinfection.
The recalled product
- Product
- Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 994
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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