Deroyal Industries Inc: Dressing, Wound, Hydrophilic
Recall Summary DeRoyal Industries is recalling Covaderm Plus Vascular Access Dressing (6"x6") because the product lacks proper sterility assurance, meaning it may not be sterile as required for a wound dressing. The product was distributed nationwide, with primary distribution in Florida and North Carolina. This is a serious recall (Class I) affecting a sterile medical device.
- Recalling firm
- DeRoyal Industries Inc
- Product
- DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
- Reason
- Sterile wound dressing, lacks sterility assurance
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-18
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution in the states of FL & NC.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/c727cfb1-8bd9-4fa4-ba4b-b3e8c63b3990