- Recalling firm
- Olympus Corporation of the Americas
- 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.
- Affected products (lot / model / serial)
- Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.
- Units affected
- 50 units
- Distribution pattern
- International distribution to the country of Japan.
- Firm location
- Center Valley, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3300-2026
- Recall initiated
- August 24, 2026
- FDA classification date
- September 25, 2026
- FDA report date
- October 7, 2026
- FDA event ID
- 99779
- Last updated on HTM Vibe
- October 13, 2026
