DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Summary
The FDA issued a Class II for DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6" by DeRoyal Industries Inc. Reason: Sterile wound dressing, lacks sterility assurance.
Details
Source
Device Recall
External ID
Z-2305-2026
Action Date
2026-06-10
Status
Ongoing
Category
device
Product Description
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Lot/Code Info: Lot: 63295141/UDI: None
Quantity Affected: 800 units
Reason for Recall
Sterile wound dressing, lacks sterility assurance
Distribution
US Nationwide distribution in the states of FL & NC.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-18
Company
Powell, TN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 403 device-related FDA actions this month.
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (DeRoyal Industries Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does DeRoyal Industries Inc have FDA actions?
DeRoyal Industries Inc has 183 FDA actions in our database, including 181 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2305-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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