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Recall Observatory FDA recall evidence

Device product

Model No. ENF-XP, RHINO-LARYNGOFIBERSCOPE

Z-0688-2024

December 04, 2023

Class II

Product summary

Firm
Shirakawa Olympus Co., Ltd.
Event
Event 93583
Status
Ongoing
Classification
Class II
Quantity
1929 US; 2200 OUS
Official record key
device-enforcement:Z-0688-2024

Official wording

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

Code information: UDI-DI: 04953170059018 All serial numbers

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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