Class II U.S. Food and Drug Administration

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus recall: Sterile wound dressing, lacks sterility assurance

Recall published 5 months ago

Sterile wound dressing, lacks sterility assurance

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Sterile wound dressing, lacks sterility assurance

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2305-2026
Published
June 10, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
DeRoyal Industries Inc
Product type
Medical devices
Units affected
800 units
Distribution
Nationwide
Made in
United States
Lot / code info
Lot: 63295141/UDI: None

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 63295141
  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 46-406
  • Vascular Access Dressing 6

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

DeRoyal Industries Inc — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: DeRoyal Industries Inc — 200 Debusk Ln, Powell, TN, 37849-4703

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was DeRoyal Industries Inc medical devices recalled?

Sterile wound dressing, lacks sterility assurance Sterile wound dressing, lacks sterility assurance

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 63295141, UDI; model number 46-406, Vascular Access Dressing 6. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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