Skip to content
Recall Observatory FDA recall evidence

Device product

Visera Hysterovideoscope Olympus HYF Type V

Z-2480-2023

July 20, 2023

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 92783
Status
Ongoing
Classification
Class II
Quantity
363 units
Official record key
device-enforcement:Z-2480-2023

Official wording

Reason: IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.

Code information: Model HYF-V, all serial numbers

Distribution pattern: US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TX, UT, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.