- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
- Affected products (lot / model / serial)
- Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
- Units affected
- 3,087 units
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
- 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-2776-2026
- Recall initiated
- June 16, 2026
- FDA classification date
- July 22, 2026
- FDA report date
- July 29, 2026
- FDA event ID
- 99109
- Last updated on HTM Vibe
- August 4, 2026