CLASS II ONGOING Device recall · Reported 7 Oct 2026 · FDA Enforcement Report
Olympus M3 Gold Autoclavable Lateral Telescope recalled
Olympus Corporation of the Americas is recalling Olympus M3 Gold Autoclavable Lateral Telescope. The recall was initiated on 24 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3300-2026
- FDA event ID
- 99779
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2026
- FDA classified
- 25 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 24 Aug 2026 | Recall initiated by company | |
| 25 Sep 2026 | Classified by FDA | +32 days |
| 7 Oct 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.
Where it was distributed
International distribution to the country of Japan.
Questions about this recall
Why was it recalled?
There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.
Which lots are affected?
Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
Where was it sold?
International distribution to the country of Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 99779This product is part of a recall event; the main page for the event is Olympus M3 Gold Autoclavable Foroblique Telescope recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
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|---|---|---|---|---|---|
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| Device | CLASS II | Olympus M3 Gold Autoclavable Foroblique Telescope recalled | Olympus Corporation of the Americas | Sterility | PA |
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