Recall Z-1222-2023
OMM Imports, Inc. dba Zero Gravity · initiated September 1, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Recreo Hair Growth Laser Comb
Codes / lots: Class 3R Zero Gravity 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.
FDA-determined cause: Error in labeling
Action taken
Letters were sent to all retailers/distributors and any direct purchasers advising of the affected device nonconformance. The letter informed customers that an updated user manual and the appropriate labels will be provided to correct the error, without charge.
Details
- Recall number
- Z-1222-2023
- Initiated
- September 1, 2022
- Posted by FDA
- March 14, 2023
- Product code
- OAP – Laser, Comb, Hair
- Quantity
- 1620 units shipped to United States
- Distribution
- Worldwide and Nationwide including DC and Puerto Rico
- Recalling firm
- OMM Imports, Inc. dba Zero Gravity, Miami Beach, FL