Recall Ledger

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

Medical deviceClass IIOngoing

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

What is being recalled

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

Why

There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

International distribution to the country of Japan.

How to tell if yours is affected

Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-3300-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedAugust 24, 2026
ReportedOctober 7, 2026
CompanyOlympus Corporation of the Americas
Company locationCenter Valley, PA, United States
Initiated byVoluntary: Firm initiated
Quantity50 units

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