DeRoyal Industries Inc — Class II medical device recall Z-2305-2026
Ongoing recall by DeRoyal Industries Inc, reported 2026-06-10, distributed nationwide. Sterile wound dressing, lacks sterility assurance
| Recall number | Z-2305-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2026-05-18 |
| Classified | 2026-06-03 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 800 units |
| Reason classes | sterility |
| Lot numbers | 63295141 |
| Model numbers | 46-406 |
Product
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason for recall
Sterile wound dressing, lacks sterility assurance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2305-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.