DuoDERM Control Gel Formula Border Dressings recalled for incorrect packaging labeling
ConvaTec recalls DuoDERM Control Gel Formula Border Dressings due to incorrect primary packaging labeling. Lot 8G03458 (expiring July 2023) was distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall for incorrect primary packaging labeling with no reported illnesses or injuries. The issue qualifies as a minor labeling error per the severity rubric.
Plain-English summary
ConvaTec, Inc is recalling DuoDERM Control Gel Formula Border Dressings (15x15cm, 1x5pk) due to incorrect primary packaging labeling. Lot number 8G03458 with expiration date July 2023 is affected, comprising 170 packs.
The affected product was distributed in the United States and Canada. US states included: California, Florida, Georgia, Illinois, Maryland, Minnesota, North Carolina, New Mexico, New Jersey, Ohio, Pennsylvania, Texas, and Virginia.
The FDA classified this as a Class II recall. Consumers with the affected product should check the lot number and expiration date to determine if their product is part of this recall.
The recalled product
- Product
- DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 170
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number 8G03458
- Expiry Jul 2023
Distribution
Related recalls
Same manufacturer · ConvaTec, Inc
See all →- HighConvaTec Esteem Body Soft Convex Urostomy Pouches Recalled for Leakage
FDA (Devices) · 2026-08-26
- ModerateAquacel Ag Surgical SP Surgical Dressing Recalled for Out-of-Specification Thickness
FDA (Devices) · 2026-07-15
- HighConvaTec EsteemBody drainable pouch REF 423657 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423653 may leak
FDA (Devices) · 2026-03-25
- HighConvaTec EsteemBody drainable pouch REF 423643 may leak
FDA (Devices) · 2026-03-25
Same hazard · mis labeling
See all →- HighBetterballen Foods Frozen Meat and Poultry Products Alerted for Undeclared Allergens
USDA FSIS · 2026-11-06
- HighEl Ruisenor De Mexico Recalls Dried Peaches for Undeclared Sulfites
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Natural Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Almond Flour for Undeclared Allergen
FDA (Food) · 2026-10-28
Similar recalls
- HighConvaTec DuoDERM wound dressings recalled for potential sterility compromise
FDA (Devices) · 2021-09-29
- HighConvaTec CarboFlex Wound Dressing Recalled for Failed Sterility Standards
FDA (Devices) · 2024-04-17
- HighWound dressings recalled because foreign matter may be on the product
FDA (Devices) · 2025-10-22
- ModerateConvaTec Recalls Mislabelled Ostomy Skin Barrier Products
FDA (Devices) · 2018-02-14
- ModerateUltrasound gel recalled for mislabeling with inappropriate use instructions
FDA (Devices) · 2023-09-20
- LowValeant Recalls Diazepam Rectal Gel Due to Missing Lot and Expiration Dates
FDA (Drugs) · 2018-08-15