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

FDA device recall Z-2305-2026 · posted 2026-06-03 · Open, Classified

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

Sterile wound dressing, lacks sterility assurance

Action taken

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 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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

NAC

Quantity affected

800 units

Distribution

US Nationwide distribution in the states of FL & NC.

Date initiated

2026-05-18

Date posted

2026-06-03

Location

Powell, TN