Official recall notice
FDA DeviceClass IINotable
FDA Recall: TDC VELOCE", 25G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT25, 9311.25G01, 9311.25
- Recall date
- 2026-06-17
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.
Recommended action
What to do
2068 boxes totaling 12408 units
Product description
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.