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DeRoyal Covaderm Plus Vascular Access Dressing
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MEDICAL DEVICE RECALLMODERATE

DeRoyal Covaderm Plus Vascular Access Dressing

DeRoyal is recalling Covaderm Plus Vascular Access Dressing (Ref 46-406) due to a lack of sterility assurance.

What to do

Stop using the affected dressing immediately and contact the manufacturer for further instructions regarding return or disposal.

Recalled
Listed
Updated
Recall No.
Z-2305-2026
Agency
FDA
Firm
DeRoyal Industries Inc
Recall ID
99044
Status
ONGOING

Recall at a glance

Quantity recalled
800 units

Why it was recalled

DeRoyal Industries is recalling Covaderm Plus Vascular Access Dressing due to a lack of sterility assurance. The affected product is identified by reference number 46-406.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

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

Lot code
63295141
UDI-DI
63295141

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification