Medical device recalls Moderate risk

Olympus Corporation of the Americas recalls ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

Recall date
May 5, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2292-2020
FDA classification
Class II
Brand / firm
Olympus Corporation of the Americas
Sold / distributed
US Nationwide distribution including in the states of FL, MI, NM, NY, OH, and OR. No international distribution.

Why it was recalled

Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.

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

What was recalled

ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.

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