PhotoMedex Recalls Iamin Medical Devices Due to Inconsistent Labeling
PhotoMedex, Inc. is recalling Iamin Moist Dressings and Hydrating Gel because their labeling does not match the intended uses approved by the FDA.
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 inconsistency rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
PhotoMedex, Inc. is recalling the Iamin Moist Dressing and Iamin Hydrating Gel. These medical devices are intended to cover wounds or burns, provide a moist environment, and protect against abrasion, friction, desiccation, and contamination.
The recall was initiated because the labeling for the Iamin family of medical devices, including printed and internet text, is not consistent with the intended uses and limitations identified at the time of the FDA clearance to market these devices.
The affected products were distributed nationwide and internationally, including in Canada. Consumers should stop using these products and contact PhotoMedex, Inc. for further instructions.
The recalled product
- Product
- Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound or burn on the skin, provide a moist wound environment and protect against abrasion, friction, desiccation and contamination.
- Manufacturer
- PhotoMedex, Inc.
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 200,188
Distribution
Distributed nationwide across the United States.
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