Recall Z-0288-2024— Olympus Corporation of the Americas

Name: FDA recall Z-0288-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-02

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-10-02. It names one FDA 510(k) clearance: K112680. Product: EVIS EXERA III Gastrointestinal Videoscope. Reason: Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2023-10-02
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K112680 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corporation·cleared 2012-02-16

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

EVIS EXERA III Gastrointestinal Videoscope

Reason for recall

Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.

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