Olympus Corporation Of The Americas: Insufflator, Laparoscopic
Recall Summary Olympus Corporation is recalling the High Flow Insufflation Unit (model UHI-4), a medical device used in laparoscopic surgery to deliver air into the body cavity during procedures. The device may unexpectedly shut off, causing the display to turn off and air delivery to stop during use. The recall affects units distributed worldwide, including throughout the United States and 29 other countries.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Reason
- Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-16
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f2d710f7-4090-4ff3-b518-4762f671335b