Miami Beach, FL, United States
OMM Imports, Inc. dba Zero Gravity recalls
1 recall recorded since 2018, most recently on 1 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 September 2022
- 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.
- Distribution
- Worldwide and Nationwide including DC and Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1222-2023
- Recreo Hair Growth Laser Comb
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.