- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices.
- Affected products (lot / model / serial)
- Model Number: 190A. UDI-DI: 00821925003538. All Lot Numbers.
- Units affected
- 3,663 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
- Firm location
- Center Valley, PA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2721-2026
- Recall initiated
- May 5, 2026
- FDA classification date
- July 10, 2026
- FDA report date
- July 22, 2026
- FDA event ID
- 98869
- Last updated on HTM Vibe
- July 28, 2026