FDA DevicesClass II
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"...
Published: June 10, 2026Recall ID: Z-2305-2026Category: devicesCountry: US
Reason for Recall / Hazard
Sterile wound dressing, lacks sterility assurance
Product Description & Identification
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Affected Products
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Additional Source Details
| Field | Value |
|---|---|
| City | Powell |
| State | TN |
| Event id | 99044 |
| Address 1 | 200 Debusk Ln |
| Code info | Lot: 63295141/UDI: None |
| Postal code | 37849-4703 |
| Report date | 20260610 |
| Product type | Devices |
| Product quantity | 800 units |
| Reason for recall | Sterile wound dressing, lacks sterility assurance |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Center classification date | 20260603 |
Overview
- Recalling FirmDeRoyal Industries Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of FL & NC.