FDA recall Z-2776-2026

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2026-06-16

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2776-2026