FDAClass IIJuly 17, 2024

Pink Luminous Breast recall

Pink Luminous Breast, Breast transilluminator

Why was Pink Luminous Breast recalled?

Firm is marketing and distributing the Pink Luminous Breast device without premarket approval

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product is not lot coded, all devices are subject

Product
Pink Luminous Breast, Breast transilluminator
Recalling firm
Silkprousa LLC
Quantity
2000 devices
Distribution
US Nationwide distribution in the states of WA, RI.
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls