Z-1222-2023 Class II Ongoing
FDA device recall Z-1222-2023 was initiated by OMM Imports, Inc. dba Zero Gravity on September 1, 2022 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 1620 units shipped to United States.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- September 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1620 units shipped to United States
Product Description
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 Pattern
Worldwide and Nationwide including DC and Puerto Rico
Code Information
Class 3R Zero Gravity Recreo Hair Growth Laser Comb