ConvaTec recalled 80,980 DuoDERM Extra Thin wound dressings distributed nationwide in the United States. The dressings may contain foreign matter, which could compromise wound care. Healthcare providers and patients should stop using the dressings and follow recall instructions.
Wound dressing may have foreign matter on the product.
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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DuoDERM Extra Thin dressings are wound dressings designed to isolate wounds from contamination while allowing moisture management. The Extra Thin variant is marketed for areas subject to friction and contouring.
Foreign matter on wound dressings can compromise wound care by introducing contaminants or causing tissue irritation. This may increase infection risk for users.
This recall is not part of a broader industry pattern.
Consumers and facilities may need to replace affected dressings and adjust wound care plans. The recall involves nearly 81,000 units and requires verification of lot codes and UDI identifiers.
Recall details are available through the FDA enforcement notice linked in the recall and on ConvaTec communications.
Refunds or replacements, if offered, typically take 4-8 weeks after verification. Exact timelines depend on ConvaTec guidance.
Retain the recall notice, product packaging, batch/lot code, and any correspondence with the manufacturer for records.
Product: DuoDERM Extra Thin dressings by ConvaTec. Model numbers: UDI-DI 768455150922; Lot 3L04808. Sold nationwide in the United States. Recall date: 2025-08-29. Quantity: 80,980 units. Price: Unknown. Manufacturer: ConvaTec, Inc. Distribution: Nationwide. Country of origin: Unknown.
No injuries or incidents have been reported.
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