Device recall

Z-2269-2024: Pink Luminous Breast, Breast transilluminator

FDA device recall · Class II · Silkprousa LLC

Key facts

Recall number (Z-number) Z-2269-2024
Recall event 94539
Product Pink Luminous Breast, Breast transilluminator
Product code LEK
Recalling firm Silkprousa LLC
Recall class Class II
Status Open, Classified
FEI number 3013213867

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)