FDAHealthMay 18, 2026

DeRoyal Industries Inc — DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

⚠️ Sterile wound dressing, lacks sterility assurance

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: May 18, 2026

US Nationwide distribution in the states of FL & NC.

What's affected?

Product: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Brand: DeRoyal Industries Inc
Lot code: 63295141/UDI:

Additional details

Lot: 63295141/UDI: None

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 800 units.

View original FDA notice →

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