Official recall notice
FDA DeviceClass IINotable
FDA Recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Recall date
- 2026-07-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Product description
Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
Affected products
Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.