Pink Luminous Breast Device (Silkprousa) – Unapproved Marketing (2024)
Marketing a medical device without proper approval can pose potential health risks.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pink Luminous Breast, Breast transilluminator
Brand
Silkprousa LLC
Lot Codes / Batch Numbers
Product is not lot coded, all devices are subject
Products Sold
Product is not lot coded, all devices are subject
Silkprousa LLC is recalling Pink Luminous Breast, Breast transilluminator due to Firm is marketing and distributing the Pink Luminous Breast device without premarket approval. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Recommended Action
Per FDA guidance
SilkProUSA issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/16/2024 via FedEx air. The notice explained the issue, the potential risk to health, and requested the consignee quarantine all inventory and notify those to whom they distributed the product. The firm is seeking the return of the affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026