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U.S. Department of Health and Human Services

Class 2 Device Recall DeRoyal Industries Covaderm Plus, Vascular Access Dressing

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 Class 2 Device Recall DeRoyal Industries Covaderm Plus, Vascular Access Dressingsee related information
Date Initiated by FirmMay 18, 2026
Date PostedJune 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2305-2026
Recall Event ID 99044
Product Classification Dressing, wound, hydrophilic - Product Code NAC
ProductDeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Code Information Lot: 63295141/UDI: None
FEI Number 1043214
Recalling Firm/
Manufacturer		 DeRoyal Industries Inc
200 Debusk Ln
Powell TN 37849-4703
For Additional Information ContactTheresa Marsee
865-938-7828
Manufacturer Reason
for Recall		Sterile wound dressing, lacks sterility assurance
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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 jmarsh@deroyal.com or by phone 865-362-6206 or email us at recalls@deroyal.com 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.
Quantity in Commerce800 units
DistributionUS Nationwide distribution in the states of FL & NC.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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