FDA Enforcement
Class II
Ongoing
Recreo Hair Growth Laser Comb
Recall: Z-1222-2023
·
Reported March 22, 2023
Enforcement
- Recall Number
- Z-1222-2023
- Event ID
- 91839
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- OMM Imports, Inc. dba Zero Gravity
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 22, 2023
- Initiation Date
- September 1, 2022
- Classification Date
- March 14, 2023
- Address
- 940 Lincoln Rd Ste 307, N/A, Miami Beach, FL, 33139-2619, United States
Description
Recreo Hair Growth Laser Comb
Reason
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.
Code Info
Class 3R Zero Gravity Recreo Hair Growth Laser Comb
Distribution
Worldwide and Nationwide including DC and Puerto Rico
Quantity
1620 units shipped to United States