FDA-Device2018-06-27Class II
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Olympus Corporation of the Americas
Hazard
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.
Sold states
Nationwide
Affected count
994
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief