Z-2305-2026Class II

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

Name: Z-2305-2026 DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Creator: DeRoyal Industries Inc
Published: 2026-05-18
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2026-05-18 / Open, Classified / root cause: sterility

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) on 2026-05-18. FDA classified it as Class II and gives the reason as "Sterile wound dressing, lacks sterility assurance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2305-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-18
Posted: 2026-06-03
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Product code: NAC Dressing, Wound, Hydrophilic
Reason for recall: Sterile wound dressing, lacks sterility assurance
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: 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 [email protected] or by phone 865-362-6206 or email us at [email protected] 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 commerce: 800 units
Distribution: US Nationwide distribution in the states of FL & NC.
Product codes and lots: Lot: 63295141/UDI: None

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2305-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2305-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

Product code NAC

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)