ConvaTec Recalls DuoDERM Dressings Over Foreign Matter Hazard
ConvaTec recalled 80,980 DuoDERM Extra Thin dressings on August 29, 2025, due to potential foreign matter contamination. The dressing is designed for dry to lightly exudating wounds and is suitable for use on sensitive areas. Patients should stop using the product immediately and follow the recall instructions provided by the manufacturer.
Quick Facts at a Glance
Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
ConvaTec
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL
Hazard Information
Wound dressing may have foreign matter on the product.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ConvaTec, Inc or your healthcare provider for instructions. Notification method: Letter
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Product Details
The recalled product is DuoDERM Extra Thin dressings, with model numbers UDI-DI: 768455150922 and Lot: 3L04808. The dressings were distributed nationwide across the United States.
The Hazard
The wound dressing may contain foreign matter, posing a risk of infection or other complications. The contamination could potentially impact the healing process.
Reported Incidents
As of the recall date, there were no reported injuries or incidents associated with this product. The recall is precautionary.
What to Do
Patients and healthcare providers should immediately stop using the DuoDERM dressings. Contact ConvaTec, Inc. or your healthcare provider for further instructions and follow the recall notification method, which includes a letter.
Contact Information
For more information, contact ConvaTec, Inc. through their official website or customer service number. Additional details are available on the FDA website.
Key Facts
Recall date: August 29, 2025
Quantity recalled: 80,980 units
High hazard level due to potential contamination
Intended for dry to lightly exudating wounds
Suitable for sensitive areas like elbows and heels
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