- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for detachment of a distal tip component of the device during use.
- Affected products (lot / model / serial)
- Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
- Units affected
- 3,360 units
- Distribution pattern
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- 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-1853-2026
- Recall initiated
- March 23, 2026
- FDA classification date
- April 17, 2026
- FDA report date
- April 29, 2026
- FDA event ID
- 98550
- Last updated on HTM Vibe
- July 24, 2026