Olympus JF-160F duodenoscopes recall
Olympus JF-160F duodenoscopes (Model NumberJF-160F)
Why was Olympus JF-160F duodenoscopes recalled?
Issuance of validated, new reprocessing procedures. 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-160F duodenoscopes (Model NumberJF-160F)
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 68
- Distribution
- Nationwide
- Recall date
- June 27, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)