FDAFDA · Food and drugs·Recall number Z-2269-2024
Pink Luminous Breast, Breast transilluminator
Published July 17, 2024 · Recall initiated: May 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Silkprousa LLC
- Distributor
- US Nationwide distribution in the states of WA, RI.
- Lot
- Product is not lot coded, all devices are subject
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.