← FDA ENFORCEMENT
Z-2305-2026Class II

DeRoyal Industries Inc

Recalling firm
DeRoyal Industries Inc
Product type
Device
Status
Ongoing
Report date
2026-06-10
Distribution
US Nationwide distribution in the states of FL & NC.
Firm state
TN
Product quantity
800 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Sterile wound dressing, lacks sterility assurance

Product description

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Code / lot info

Lot: 63295141/UDI: None

Other recalls SPEQ maps to Environmental Monitoring
2026-07-22Class IFrutas y Hortalizas del Sur S.A.2026-07-22Class IIGELLERT GLOBAL GROUP2026-07-22Class IIChiesi USA, Inc.2026-07-22Class IICareFusion 213, LLC
See all Environmental Monitoring recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.