Recall Z-0688-2024— Shirakawa Olympus Co., Ltd.

Name: FDA recall Z-0688-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-04

Class II · Ongoing

Class II FDA medical device recall by Shirakawa Olympus Co., Ltd., initiated 2023-12-04. It names one FDA 510(k) clearance: K221660. Product: Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE. Reason: Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible..

Recalling firm: Shirakawa Olympus Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-04
Firm location: Nishishirakawa-Gun, Japan

510(k) clearances named in this recall

1 on FDA's record

K221660 — RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XPOlympus Medical Systems Corp.·cleared 2022-12-28

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

Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

Reason for recall

Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.

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