FDA DeviceClass IINotable

FDA Recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Date: 2026-07-29
Brand: Olympus Corporation of the Americas
Category: Medical Device
FDA Class: Class II

Description

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Hazard

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Remedy

3,087 units

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