Device recall
Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.
- Recall number
- Z-3299-2026
- Event id
- 99779
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Report date
- Oct 7, 2026
- Posted
- Sep 25, 2026
- Initiated
- Aug 24, 2026
- Center classification date
- Sep 25, 2026
- Product code
- HIH
- Device type
- Hysteroscope (And Accessories)
- 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.
- Root cause
- Process control
- Quantity
- 72 units
- Code info
- Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.
- Distribution
- International distribution to the country of Japan.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K890328
- Location
- Center Valley, PA, United States