Olympus Corporation of the Americas: Medical Device Recall in 2018 - (Recall #: Z-2269-2018)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2018.
Data Source: FDA.
Product Description:
Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Product Classification:
Class II
Date Initiated: May 11, 2018
Date Posted: June 27, 2018
Recall Number: Z-2269-2018
Event ID: 79998
Reason for Recall:
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.
Status: Terminated
Product Quantity: 994
Code Information:
All
Distribution Pattern:
Nationwide
Voluntary or Mandated:
Voluntary: Firm initiated