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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ConvaTec
- Product type
- Wound Dressing
- Model numbers
- UDI-DI: 768455150922, Lot: 3L04808
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
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.
Practical Guidance
How to identify if yours is affected
- 1. Locate the product packaging and labeling.
- 2. Check for UDI-DI 768455150922 on the label.
- 3. Check for Lot 3L04808 on the dressing or carton.
- 4. Confirm whether the product is within the recall scope.
- 5. Contact ConvaTec for instructions.
Where to find product info
Recall details are available through the FDA enforcement notice linked in the recall and on ConvaTec communications.
What timeline to expect
Refunds or replacements, if offered, typically take 4-8 weeks after verification. Exact timelines depend on ConvaTec guidance.
If the manufacturer is unresponsive
- Document all communications with ConvaTec.
- If the company is slow to respond, file a complaint with the FDA recall program and your local consumer protection office.
How to prevent similar issues
- Verify packaging integrity before use.
- Ask healthcare facilities for recall status when using wound dressings.
- Check for updated packaging or batch codes when purchasing dressings in the future.
Documentation advice
Retain the recall notice, product packaging, batch/lot code, and any correspondence with the manufacturer for records.
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Product Details
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.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide US distribution
- Hazard: foreign matter on product
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