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Home › FDA recalls › DeRoyal Industries Inc. Ref 46-406
CLASS II · ModerateFDA

DeRoyal Industries Inc recalls DeRoyal Industries Inc. Ref 46-406

📅 May 18, 2026 · 📍 Nationwide
Recalling company
DeRoyal Industries Inc
Product
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason
Sterile wound dressing, lacks sterility assurance
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 18, 2026
Reported
Jun 10, 2026
Distribution
US Nationwide distribution in the states of FL & NC.
Status
Ongoing
Quantity
800 units
Lot / codes
Lot: 63295141/UDI: None
Company location
Powell, TN
Recall type
Voluntary: Firm initiated
Recall number
Z-2305-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2305-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.