FDA recall, , Moderate risk
DeRoyal Covaderm Plus Vascular Access Dressings
Covaderm Plus, Vascular Access Dressing lacks sterility assurance.
Summary by Recall Canary from the FDA notice
What happened
DeRoyal Industries Inc., of Powell, Tennessee, recalled 800 units of its Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm) because the sterile wound dressing lacks sterility assurance. The company began the recall on May 18, 2026, and the FDA added it to its Enforcement Report on June 3, 2026, with distribution in the states of Florida and North Carolina.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- UDI-DI
- 63295141
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Florida & North Carolina.
- Company
- DeRoyal Industries IncPowell, Tennessee
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99044
- Recall number
- Z-2305-2026
- Quantity recalled
- 800 units
All recalls from DeRoyal Industries Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
