Recall Z-1222-2023 ยท OAP Laser, Comb, Hair
OMM Imports, Inc. dba Zero Gravity
Recreo Hair Growth Laser Comb
| Date | Mar 14, 2023 (initiated Sep 1, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 1620 units shipped to United States |
| Distribution | Worldwide and Nationwide including DC and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183329 | Laser Hair Therapy Omm Imports, Inc. D/B/A Zero Gravity, Jan 16, 2019 |