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Recall

Class II — Olympus Corporation of the Americas

Recalling firmOlympus Corporation of the Americas
ClassificationClass II
StatusOngoing
ReasonPotential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
ProductOlympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
Quantity3,087 units
DistributionWorldwide 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.
Initiated2026-06-16
Classified2026-07-22
Recall numberZ-2776-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Olympus Corporation of the Americas (Z-2776-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99109/

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