Olympus M3 Gold Autoclavable Foroblique Telescope 30 and Lateral Telescope 70
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Olympus Corporation of the Americas began a recall on August 24, 2026, for the Olympus M3 Gold Autoclavable Lateral Telescope 70 and the Olympus M3 Gold Autoclavable Foroblique Telescope 30, involving 50 units and 72 units respectively, due to discrepancies in sterilization parameters between the Instructions for Use and the Japanese package insert.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the model number and UDI-DI listed under your product.
Olympus M3 Gold Autoclavable Foroblique Telescope 30.
- Model
- M3-30A
- UDI-DI
- 00821925005679
- Lot
- All Serial Numbers.
Olympus M3 Gold Autoclavable Lateral Telescope 70.
- Model
- M3-70A
- UDI-DI
- 00821925005686
- Lot
- All Serial Numbers.
Details
- Company began the recall
- Sold in
International distribution to the country of Japan.
- Event ID
- 99779
- Recall numbers
- Z-3299-2026 to Z-3300-2026
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
