FDA recall Z-1222-2023

OMM Imports, Inc. dba Zero Gravity · Class II · device

Product

Recreo Hair Growth Laser Comb

Reason for recall

The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.

Distribution

Worldwide and Nationwide including DC and Puerto Rico

Key facts

Status: Ongoing
Initiation date: 2022-09-01
Report date: 2023-03-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Miami Beach, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1222-2023