Silkprousa LLC: Pink Luminous Breast Device Recalled for Lack of FDA Approval

Agency Publication Date: July 5, 2024

Summary

Silkprousa LLC is recalling approximately 2,000 units of the Pink Luminous Breast device, which is sold as a breast transilluminator. The device was being marketed and distributed without the required premarket approval from the FDA, which is necessary to ensure the device is safe and effective for its intended use. Consumers should contact their healthcare provider or the manufacturer regarding the use of this device. This recall affects all units of the product as they were not assigned specific lot codes.

Risk

Because this device did not undergo the required FDA premarket approval process, its safety and effectiveness for breast screening or transillumination have not been verified, potentially leading to unreliable results or unrecognized health risks.

What You Should Do

Identify if you have the affected product by looking for the 'Pink Luminous Breast' device (Breast transilluminator).
Check your device for any lot codes; note that because this product was not lot coded by the manufacturer, all 2,000 units distributed are considered subject to this recall.
Contact your healthcare provider or Silkprousa LLC directly for further instructions regarding the device and to discuss potential refund or return options.
If you have used this device for health screening purposes, consult with a medical professional to ensure you receive appropriate and approved diagnostic care.
For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Consult healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Pink Luminous Breast, Breast transilluminator

Lot Numbers:

All devices (product is not lot coded)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94539

Status: Active

Manufacturer: Silkprousa LLC

Sold By: Silkprousa LLC

Manufactured In: United States

Units Affected: 2000 devices

Distributed To: Washington, Rhode Island

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have the affected product by looking for the 'Pink Luminous Breast' device (Breast transilluminator).

Check your device for any lot codes; note that because this product was not lot coded by the manufacturer, all 2,000 units distributed are considered subject to this recall.

Contact your healthcare provider or Silkprousa LLC directly for further instructions regarding the device and to discuss potential refund or return options.

If you have used this device for health screening purposes, consult with a medical professional to ensure you receive appropriate and approved diagnostic care.

For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.