Medical device recalls Moderate risk

Silkprousa LLC recalls Pink Luminous Breast, Breast transilluminator

Recall date
May 20, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2269-2024
FDA classification
Class II
Brand / firm
Silkprousa LLC
Sold / distributed
US Nationwide distribution in the states of WA, RI.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Pink Luminous Breast, Breast transilluminator

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