PlainRecalls
FDA Devices Moderate Class II Ongoing

Visera Hysterovideoscope Olympus HYF Type V

Reported: September 6, 2023 Initiated: July 20, 2023 #Z-2480-2023

Product Description

Visera Hysterovideoscope Olympus HYF Type V

Reason for Recall

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

Details

Units Affected
363 units
Distribution
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.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
Visera Hysterovideoscope Olympus HYF Type V. Recalled by Olympus Corporation of the Americas. Units affected: 363 units.
Why was this product recalled?
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2480-2023.