FDA-Device2026-10-07Class IIMISBRANDING
Olympus M3 Gold Autoclavable Foroblique Telescope recalled for sterilization parameter discrepancies
What this means
Olympus Corporation of the Americas has recalled the M3 Gold Autoclavable Foroblique Telescope 30 (Model M3-30A) due to differences between the sterilization instructions in the U.S. labeling and the Japanese package insert. Healthcare facilities using this device need to verify they are following the correct sterilization parameters.
- Check your facility's inventory for Model M3-30A (Serial Numbers: all affected)
- Review the sterilization parameters in both the Instructions for Use and any Japanese package insert
- Contact Olympus Corporation of the Americas for clarification on the correct sterilization method
- Do not use the device until you have confirmed the proper sterilization parameters
The agency's original wording
Hazard
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Intended for
Adults
Illnesses reported
None reported
Sold states
International distribution to the country of Japan.
Affected count
72 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3299-2026More Olympus recalls
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