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Z-2305-2026Class II

DeRoyal Industries Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
DeRoyal Industries Inc
Product type
Device
Status
Ongoing
Report date
2026-06-10
Distribution
US Nationwide distribution in the states of FL & NC.
Firm state
TN
Product quantity
800 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Sterile wound dressing, lacks sterility assurance

Product description

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

Code / lot info

Lot: 63295141/UDI: None

Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →