Recall Z-2305-2026
- Recall number
- Z-2305-2026
- Event number
- 99044
- Firm
- DeRoyal Industries Inc
- Firm FEI
- 1043214
- Product code
- NAC
- Status
- Open, Classified
- Initiated
- 2026-05-18
- Posted
- 2026-06-03
- Root cause
- Under Investigation by firm
- 510(k) numbers
- K914779, K925841, K082208, K914575
Product#
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Reason for Recall#
Sterile wound dressing, lacks sterility assurance