United StatesOlympus High Flow Insufflation Units used for insufflation of the abdominal cavity and automatic suction and smoke evacuation — model numbers UHI, UHI-2, and UHI-3 (UDI‑DI for UHI‑3: 04953170140280, 04953170140297) — are being recalled. The recall was initiated because a software algorithm issue may lead to overpressure events. The devices were distributed nationwide by Olympus Corporation of the Americas.
What's being recalled
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.
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA, United States.
How to identify it
Model Number: UHI; UDI-DI: N/A; All Serial Numbers Model Number: UHI-2; UDI-DI: N/A; All Serial Numbers Model Number: UHI-3; UDI-DI: 04953170140280, 04953170140297; All Serial Numbers.
The hazard
Issue with software algorithm which may lead to overpressure events.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Nationwide distribution
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)