Breast transilluminator recalled due to lack of FDA premarket approval
Silkprousa LLC is recalling the Pink Luminous Breast transilluminator because the device was marketed and distributed without FDA premarket approval. All 2,000 units distributed nationwide are subject to recall.
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 an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is regulatory—distribution without required premarket approval—rather than an identified safety defect. Without reported harm and with no specific product malfunction described, this falls under precautionary/regulatory recalls.
Plain-English summary
Silkprousa LLC is recalling the Pink Luminous Breast, a breast transilluminator device. The firm has been marketing and distributing the device without obtaining FDA premarket approval, which is required for medical devices in this category before they can be legally sold in the United States.
The recall affects all 2,000 units of the device that were distributed nationwide. Because the product is not lot-coded, all manufactured devices are included in this recall.
Consumers who have purchased this device should stop using it and contact Silkprousa LLC or their healthcare provider with any questions or concerns.
The recalled product
- Product
- Pink Luminous Breast, Breast transilluminator
- Manufacturer
- Silkprousa LLC
- Affected units
- 2,000
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)
- Product is not lot coded
- all devices are subject
Distribution
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