Z-2776-2026 Class II Ongoing
FDA device recall Z-2776-2026 was initiated by Olympus Corporation of the Americas on June 16, 2026 and is designated Class II. Reason for recall: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. The recall status is ongoing. Affected quantity: 3,087 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 29, 2026
- Initiation Date
- June 16, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,087 units
Product Description
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Reason for Recall
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
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.
Code Information
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.