Recall Z-2269-2024— Silkprousa LLC
Class II · Ongoing
Class II FDA medical device recall by Silkprousa LLC, initiated 2024-05-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Pink Luminous Breast, Breast transilluminator. Reason: Firm is marketing and distributing the Pink Luminous Breast device without premarket approval.
- Recalling firm
- Silkprousa LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-20
- Firm location
- Miami, FL, United States
Product description
Pink Luminous Breast, Breast transilluminator
Reason for recall
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Data sourced from openFDA. This site is unofficial and independent of the FDA.