Bellus Medical Recalls SKINFUSE Kit Due to Mislabeling
Bellus Medical is recalling SKINFUSE Rescue Calming Complex Kits because they were packaged with a mislabeled medical product.
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: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Bellus Medical is recalling approximately 6,007 units of the SKINFUSE Rescue Calming Complex Kit. The recall was initiated because the cosmetic kit was packaged with a mislabeled medical product. The kit contains the SKINFUSE LIFT HG, which is a hydrogel wound dressing intended to protect against abrasion and friction during microneedling procedures.
The affected products are identified by Bellus Lot 16053, which is listed on the SKINFUSE LIFT HG tube within the kit. The recall covers units distributed nationwide in the United States.
Consumers who have this product should stop using it and contact Bellus Medical for further instructions.
The recalled product
- Product
- SKINFUSE Resuce Calming Complex Kit containing: SKINFUSE LIFT HG - Product Usage: The SKINFUSE Rescue Calming Complex is intend to be used to soothe and calm skin (cosmetic). The SKINFUSE LIFT HG is a hydrogel wound dressing to protect against abrasion and friction during the…
- Manufacturer
- Bellus Medical
- Category
- Medical Device — Wound Dressing
- Hazard
- Affected units
- 6,007
Distribution
Distributed nationwide across the United States.
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