FDA / Health Canada # RA-74494

The Olympus High Flow Insufflation Unit inflates the abdomen or colon with carbon dioxide gas. The unit may be used during laparoscopic or endoscopic surgeries, such as minimally invasive abdominal surgeries, colonoscopies, or vein harvesting. The unit also provides automatic suction and smoke evacuation.

Olympus is recalling its Olympus High Flow Insufflation Unit because the unit may over-insufflate (inflate) air into the body with no warning or alarm.

For more information, visit:
FDA  https://www.fda.gov/medical-devices/medical-device-recalls/olympus-recalls-olympus-high-flow-insufflation-unit-due-over-inflation?utm_medium=email&utm_source=govdelivery

Health Canada  https://recalls-rappels.canada.ca/en/alert-recall/uhi-4-high-flow-insufflation-system-insufflator?utm_source=gc-notify&utm_medium=email&utm_content=en&utm_campaign=hc-sc-rsa-22-23&