The Recall Desk
ModerateFDA (Devices)·Z-2480-2023·Announced 2023-09-06

Olympus Hysterovideoscope Labeling Revised for Sterilization Parameters and Cleaning Instructions

Olympus is updating labeling for 363 Visera Hysterovideoscope devices nationwide to correct ethylene oxide sterilization parameters and eliminate certain reusable cleaning brush recommendations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II labeling revision with no reported hospitalizations or injuries. The recall addresses precautionary updates to sterilization parameters and cleaning procedures to ensure proper device safety and sterility.

Plain-English summary

Olympus Corporation of the Americas is recalling 363 units of the Visera Hysterovideoscope Olympus HYF Type V, a surgical instrument used in hysteroscopic procedures. The recall involves Model HYF-V with all serial numbers.

The company is updating the Instructions for Use (IFU) labeling to revise ethylene oxide (EtO) gas sterilization parameters and to eliminate recommendations for reusable cleaning brushes. These labeling updates ensure proper sterilization and device preparation.

The affected devices were distributed nationwide across 33 states. Users of the Visera Hysterovideoscope should obtain the updated IFU labeling and ensure compliance with the revised sterilization and cleaning instructions before further use of the device.

The recalled product

Product
Visera Hysterovideoscope Olympus HYF Type V
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device
Hazard
  • labeling-error
  • sterilization-hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model HYF-V
  • all serial numbers

Distribution

Distributed nationwide across the United States.

Related recalls

Same category