Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls Olympus JF-160F duodenoscopes (Model NumberJF-160F)

Recall date
May 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2270-2018
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
Nationwide

Why it was recalled

Issuance of validated, new reprocessing procedures. 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-160F duodenoscopes (Model NumberJF-160F)

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