FDA Medical Device Recalls (openFDA)
OMM Imports, Inc. dba Zero Gravity: Recreo Hair Growth Laser Comb
- Recall number
- Z-1222-2023
- Recalling firm
- OMM Imports, Inc. dba Zero Gravity
- Product
- Recreo Hair Growth Laser Comb
- Status
- Open, Classified
- Initiated
- 2022-09-01
- Posted
- 2023-03-14
- Terminated
- not on file
- 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
- Lot, serial or model codes
- Class 3R Zero Gravity Recreo Hair Growth Laser Comb
- 510(k) numbers
- ["K183329"]
- PMA numbers
- not on file
- Product code
- OAP
- Firm FEI
- 3012327767
- Firm city
- Miami Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28