Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Ca
- Recall date
- 2026-05-06
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to complaints of device breakage at the traction force gauge to handle joint.
Recommended action
What to do
49,175 devices
Product description
Due to complaints of device breakage at the traction force gauge to handle joint.