Class II — Olympus Corporation of the Americas
| Recalling firm | Olympus Corporation of the Americas |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. |
| Product | Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A. |
| Quantity | 50 units |
| Distribution | International distribution to the country of Japan. |
| Initiated | 2026-08-24 |
| Classified | 2026-09-25 |
| Recall number | Z-3300-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-14. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Olympus Corporation of the Americas (Z-3300-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-14. https://regwarden.com/recall/99779/
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