FDA Medical Device · Z-2305-2026

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

Class II · Ongoing

Sterile wound dressing, lacks sterility assurance

Affected lots / codes — check yours against thisLot: 63295141/UDI: None

Recalling firm: DeRoyal Industries Inc, Powell, TN
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 800 units
Distribution: US Nationwide distribution in the states of FL & NC.
Recall initiated: May 18, 2026
Classified: June 3, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2305-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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