Z-2305-2026 Class II Ongoing
FDA device recall Z-2305-2026 was initiated by DeRoyal Industries Inc on May 18, 2026 and is designated Class II. Reason for recall: Sterile wound dressing, lacks sterility assurance The recall status is ongoing. Affected quantity: 800 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- May 18, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 800 units
Product Description
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason for Recall
Sterile wound dressing, lacks sterility assurance
Distribution Pattern
US Nationwide distribution in the states of FL & NC.
Code Information
Lot: 63295141/UDI: None