Silkprousa LLC: Medical Device Recall in 2024 - (Recall #: Z-2269-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Pink Luminous Breast, Breast transilluminator

Product Classification:

Class II

Date Initiated: May 20, 2024

Date Posted: July 17, 2024

Recall Number: Z-2269-2024

Event ID: 94539

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2000 devices

Code Information:

Product is not lot coded, all devices are subject

Distribution Pattern:

US Nationwide distribution in the states of WA, RI.

Voluntary or Mandated:

Voluntary: Firm initiated