FDA Medical Device Recalls (openFDA)
DeRoyal Industries Inc: DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Recall number
- Z-2305-2026
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Status
- Open, Classified
- Initiated
- 2026-05-18
- Posted
- 2026-06-03
- Terminated
- not on file
- Reason
- Sterile wound dressing, lacks sterility assurance
- 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 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
- 800 units
- Distribution
- US Nationwide distribution in the states of FL & NC.
- Lot, serial or model codes
- Lot: 63295141/UDI: None
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NAC
- Firm FEI
- 1043214
- Firm city
- Powell
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28