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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 363
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
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