FDA Medical devices recall ·
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 recall
- Recall number
- Z-2776-2026
- Date
- (initiated June 16, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3,087 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Why was it recalled?
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.
Distribution
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.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2776-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.