Olympus Corporation of the Americas Visera Hysterovideoscope Olympus HYF Type V Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Visera Hysterovideoscope Olympus HYF Type V
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model HYF-V, all serial numbers
Products Sold
Model HYF-V, all serial numbers
Olympus Corporation of the Americas is recalling Visera Hysterovideoscope Olympus HYF Type V due to IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Recommended Action
Per FDA guidance
A customer letter was issued on July 20, 2023. Customers were advised that the Instructions for use were updated. Customers are asked to complete a response form of acknowledgement and submit to Sedgwick at olympus8606@sedgwick.com or Fax 866-557-1242.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026