DeRoyal Industries Inc. Ref 46-406 recall (DeRoyal Industries Inc)
Medical deviceClass IIOngoing
Summary: DeRoyal Industries Inc is recalling DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm). Reason: Sterile wound dressing, lacks sterility assurance.
What is being recalled
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Why
Sterile wound dressing, lacks sterility assurance
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of FL & NC. (states named: Florida, North Carolina)
How to tell if yours is affected
Lot: 63295141/UDI: None
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2305-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 18, 2026 |
| Reported | June 10, 2026 |
| Company | DeRoyal Industries Inc |
| Company location | Powell, TN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 800 units |
More recalls from DeRoyal Industries Inc · all medical device recalls · recalls from May 2026