Recreo Hair Growth Laser Comb
FDA device recall Z-1222-2023 · posted 2023-03-14 · Open, Classified
Recall details
- Recalling firm
- OMM Imports, Inc. dba Zero Gravity
- 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.
- 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.
- Root cause
- Error in labeling
- Status
- Open, Classified
- Product code
- OAP
- Quantity affected
- 1620 units shipped to United States
- Distribution
- Worldwide and Nationwide including DC and Puerto Rico
- Date initiated
- 2022-09-01
- Date posted
- 2023-03-14
- Location
- Miami Beach, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Laser Hair Therapy (K183329) | Omm Imports, Inc. D/B/A Zero Gravity | 2019-01-16 |