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Class IIOngoing

Olympus Corporation of the Americas recalls 2 products

Recall date · record updated Oct 7, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Olympus Corporation of the Americas
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
International distribution to the country of Japan.
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99779…

Products (2)

  1. Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.

    Codes/lots: Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.Quantity: 72 unitsRecall no. Z-3299-2026Class II

  2. Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.

    Codes/lots: Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.Quantity: 50 unitsRecall no. Z-3300-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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