Olympus JF-140F duodenoscopes recall
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Why was Olympus JF-140F duodenoscopes recalled?
Issuance of validated, new reprocessing procedures. 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All
- Product
- Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 994
- Distribution
- Nationwide
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)