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Open, Classified

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

FDA Recall Z-2305-2026 · Posted 2026-06-03

Recall StatusOpen, Classified
Product CodeNAC
Date Initiated2026-05-18
Product Quantity800 units

Reason for Recall

Sterile wound dressing, lacks sterility assurance

Firm Action

On May 18, 2026, DeRoyal Industries, Inc. issued a Urgent Medical Device Recall Notification to affected consignees via Email. DeRoyal ask consignees to take the following actions 1. identify affected product numbers in your inventory and place in quarantine to prevent further use. Please destroy all product identified 2)If you have questions regarding the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-6206 or email us at [email protected] 3)PLEASE COMPLETE AND RETURN THE NOTICE OF DESTRUCTION FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 4)If you distributed this product to other facilities or departments within your institution, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer listing and we will contact them.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution in the states of FL & NC.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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