Class II
Medical Device Recall: Pink Luminous Breast, Breast transilluminator
Silkprousa LLC · May 20, 2024
Reason for Recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Distribution
US Nationwide distribution in the states of WA, RI.
States Affected
NATIONWIDE
Quantity Affected
2000 devices
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2269-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.