Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Pink Luminous Breast, Breast transilluminator

FDA Recall Z-2269-2024 · Posted 2024-07-05

Recalling FirmSilkprousa LLC
Recall StatusOpen, Classified
Product CodeLEK
Date Initiated2024-05-20
Product Quantity2000 devices

Reason for Recall

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

Firm Action

SilkProUSA issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/16/2024 via FedEx air. The notice explained the issue, the potential risk to health, and requested the consignee quarantine all inventory and notify those to whom they distributed the product. The firm is seeking the return of the affected product.

Root Cause

No Marketing Application

Distribution Pattern

US Nationwide distribution in the states of WA, RI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑