FDA Device recall Z-2305-2026
DeRoyal Industries Inc
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of DeRoyal Industries Inc by Deroyal Industries, citing sterile wound dressing, lacks sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2305-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Deroyal Industries |
| Distribution | US |
Product
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason
Sterile wound dressing, lacks sterility assurance
Identifiers
| code_info | Lot: 63295141/UDI: None |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2305-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.