Pink Luminous Breast — Class II medical device recall Z-2269-2024
Ongoing recall by Silkprousa LLC, reported 2024-07-17, distributed nationwide. Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
| Recall number | Z-2269-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Silkprousa LLC, Miami, FL, United States |
| Recall initiated | 2024-05-20 |
| Classified | 2024-07-05 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,000 devices |
Product
Pink Luminous Breast, Breast transilluminator
Reason for recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2269-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.