FDA-Device2026-02-25Class IPROCESSING DEFECT
Olympus High Flow Insufflation Unit recalled for software overpressure risk
OTHERNationwide distribution
Stop using Olympus insufflation unit Model UHI
Olympus Corporation is recalling the High Flow Insufflation Unit (Model UHI) used during abdominal surgery due to a software problem that may cause overpressure events. The device is used to inflate the abdominal cavity and remove smoke during laparoscopic surgery. No injuries have been reported.
- Stop using the Olympus UHI insufflation unit immediately
- Contact Olympus Corporation for replacement or repair instructions
- Notify your surgical facility or hospital that you have this device
Hazard
Issue with software algorithm which may lead to overpressure events.
Sold states
Nationwide distribution
Affected count
18 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1352-2026More Olympus Corporation of the Americas recalls
- FDA-Device2026-04-08Olympus SOLTIVE Premium laser system recalled for defective power supply
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- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
- FDA-Device2026-04-01Olympus MAJ-1443 and MAJ-1444 endoscope suction valves no longer compatible with OER-Pro and OER-Elite reprocessors
- FDA-Device2026-04-01Olympus PKS Cutting Forceps recalled for defective welds causing jaw breakage
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