Official recall notice
FDA DeviceClass IINotable
FDA Recall: CLARITY II Laser System; Model No. 1110200210.
- Recall date
- 2026-03-18
- Brand
- Lutronic Corporation
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Reports of devices sparking/popping and potentially burning patients.
Recommended action
What to do
1,525 units
Product description
Reports of devices sparking/popping and potentially burning patients.