Official recall notice
FDA DeviceClass IINotable
FDA Recall: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Recall date
- 2026-06-10
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Sterile wound dressing, lacks sterility assurance
Recommended action
What to do
800 units
Product description
Sterile wound dressing, lacks sterility assurance