FDA recall Z-2269-2024

Product

Pink Luminous Breast, Breast transilluminator

Reason for recall

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

Distribution

US Nationwide distribution in the states of WA, RI.

Key facts

Status

Ongoing

Initiation date

2024-05-20

Report date

2024-07-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2024