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Olympus Corporation of the Americas: Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.

Medical DevicesSource: FDA (device) · Date: 2026-10-07

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Olympus Corporation of the Americas
Product
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the country of Japan.
Recall initiated
2026-08-24
Code info
Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
Product quantity
50 units
Voluntary mandated
Voluntary: Firm initiated
City
Center Valley
State
PA
Country
United States
Event id
99779
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