“DeRoyal Covaderm Plus Dressing Recall: Sterility Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49155-deroyal-covaderm-plus-dressing-recall-sterility-risk. Based on FDA recall #Z-2305-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2305-2026%22&limit=1).
The FDA announced on May 18, 2026, that DeRoyal Industries Inc. is recalling Covaderm Plus Vascular Access Dressing 6"x6" because the sterile wound dressing lacks sterility assurance. The firm initiated this voluntary Class II recall affecting 800 units distributed in Florida and North Carolina.
The recall involves sterile wound dressings that lack sterility assurance. The FDA classified this as a Class II recall due to the potential risk associated with the non-sterile product.
Context
GovInfoNow's records show DeRoyal Industries Inc. has 29 other recalls on record since June 7, 2017. Recent brand recalls include a myocardial probe recall on August 20, 2026, for incorrect needle size and suction tubing recalls on January 31 and January 15, 2025, for inadequate suction risks. Other recent recalls of similar products include Medline Surgical Drapes (January 7, 2026), Medline Sterile Saline Wound Wash (January 5, 2026), and Medline ARTERIAL LINE INSERTION KIT (June 12, 2026).
How to tell if you have this one
Check for the model 'Covaderm Plus' with size 6"x6" (15cmx15cm). The lot number 63295141 is associated with this recall.
Brand
DeRoyal
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Dressing Details
Look for the model number 'Covaderm Plus' and size 6"x6" (15cmx15cm) on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL & NC.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Florida, North Carolina.
Recall timeline
FDA published this recall 23 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2305-2026 (May 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2305-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.