HIGHFDA DEVICE

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

Sterile wound dressing, lacks sterility assurance

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 18, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 18, 2026
Hazard Level
HIGH
Brand
DeRoyal Industries
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
DeRoyal Industries
Model numbers
Lot: 63295141/UDI: None
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 18, 2026

  2. Reported by FDA DEVICE

    June 10, 2026

  3. RecallRadar source check

    June 16, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Sterile wound dressing, lacks sterility assurance

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact DeRoyal Industries Inc or your healthcare provider for instructions

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Full Description

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm). Reason: Sterile wound dressing, lacks sterility assurance. Classification: Class II. Quantity: 800 units. Distribution: US Nationwide distribution in the states of FL & NC.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Model Numbers
Lot: 63295141/UDI: None
Affected States
ALL
Report Date
June 10, 2026
Recall Status
ACTIVE