Official recall notice
FDA DeviceClass IINotable
FDA Recall: TDC VELOCE", 27G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT27, 9311.27G01, 9311.27
- 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
261 boxes totaling 1566 units
Product description
An increase in incidence in complaints of a loose outer knife and reports of the outer knife becoming loose during use.