FDA Device recall Z-2269-2024
Pink Luminous Breast, Breast transilluminator
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of Pink Luminous Breast, Breast transilluminator by Silkprousa, citing firm is marketing and distributing the Pink Luminous Breast device without premarket approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2269-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-20 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Silkprousa |
| Distribution | US |
Product
Pink Luminous Breast, Breast transilluminator
Reason
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Identifiers
| code_info | Product is not lot coded, all devices are subject |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2269-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.