Miami, FL, United States
Silkprousa LLC recalls
1 recall recorded since 2018, most recently on 20 May 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 May 2024
- Reason
- Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
- Distribution
- US Nationwide distribution in the states of WA, RI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2269-2024
- Pink Luminous Breast, Breast transilluminator
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.