FDA recall Z-2305-2026

Product

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

Reason for recall

Sterile wound dressing, lacks sterility assurance

Distribution

US Nationwide distribution in the states of FL & NC.

Key facts

Status

Ongoing

Initiation date

2026-05-18

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Powell, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2305-2026