FDA Medical devices recall ·
DeRoyal Industries Inc recall
- Recall number
- Z-2305-2026
- Date
- (initiated May 18, 2026)
- Company / brand
- DeRoyal Industries Inc
200 Debusk Ln, Powell, TN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 800 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Why was it recalled?
Sterile wound dressing, lacks sterility assurance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: 63295141/UDI: None
Distribution
US Nationwide distribution in the states of FL & NC.
States: Florida North Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2305-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.