medical Class II Updated 2018-06-27

Olympus Corporation of the Americas recalls Olympus JF-140F duodenoscopes (Model NumberJF-140F)

Recalled Product

Olympus JF-140F duodenoscopes (Model NumberJF-140F)


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All
View official government recall

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