HIGH

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

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
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeWound Dressing
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI-DI: 768455150922
Lot: 3L04808
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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