Recall Z-2292-2020— Olympus Corporation of the Americas

Name: FDA recall Z-2292-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-05

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-05-05, terminated 2020-09-18. It names one FDA 510(k) clearance: K181240. Product: ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.. Reason: Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2020-05-05
Terminated: 2020-09-18
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181240 — Rhino-Laryngo Fiberscope Olympus ENF-GP2Olympus Medical Systems Corp.·cleared 2018-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.