FDAMay 18, 2026device
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Sterile wound dressing, lacks sterility assurance
What to do
FDA enforcement status: Ongoing
Brands named
deroyal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement2025-01-31
- FDADeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C512, 71-C520, Tubing is intended for fluid movement2025-01-15
- FDADeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-062024-10-03
- FDADeRoyal C-SECTION TRACEPACK, REF 89-9338-062024-10-03
- FDADeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-062024-10-03
- FDADeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.062024-10-03
- FDAGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART2024-02-13
- FDADeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-105722023-11-22
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