Fresh Recalls

FDAClass II · Medical device · Recall Z-2305-2026 · Recalled June 10, 2026

DeRoyal Industries Inc recall — DeRoyal Industries Inc

Agency report date: June 10, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
DeRoyal Industries Inc
Company / brand
DeRoyal Industries
Lot / serial / date codes
Lot: 63295141/UDI: None
Distribution
US Nationwide distribution in the states of FL & NC.
Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Sterile wound dressing, lacks sterility assurance

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: DeRoyal Industries Inc recall status

3. Open the official notice or contact

Official recall ID
Z-2305-2026
Brand
All DeRoyal Industries recalls
Classification
Class II
Units affected
800 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Powell, TN, United States
Firm address
200 Debusk Ln, 37849-4703

Identifying details (verbatim from the notice)

Product codes / lots
Lot: 63295141/UDI: None
Distribution
US Nationwide distribution in the states of FL & NC.
FDA event ID
99044
Recall initiated
May 18, 2026
FDA classified
June 3, 2026
FDA report date
June 10, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 8, 2026 at 6:00 PM UTC.

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