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

Recall date

May 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2269-2018

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

Nationwide

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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