Z-1222-2023Class II

Recreo Hair Growth Laser Comb

Name: Z-1222-2023 Recreo Hair Growth Laser Comb
Creator: OMM Imports, Inc. dba Zero Gravity
Published: 2022-09-01
License: https://open.fda.gov/license/

Omm Imports, Inc. D/B/a Zero Gravity / initiated 2022-09-01 / Open, Classified / root cause: labeling and UDI

FDA source

OMM Imports, Inc. dba Zero Gravity began a recall of Recreo Hair Growth Laser Comb on 2022-09-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1222-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-01
Posted: 2023-03-14
Recalling firm: Omm Imports, Inc. D/B/a Zero Gravity
Product: Recreo Hair Growth Laser Comb
Product code: OAP Laser, Comb, Hair
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1620 units shipped to United States
Distribution: Worldwide and Nationwide including DC and Puerto Rico
Product codes and lots: Class 3R Zero Gravity Recreo Hair Growth Laser Comb

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1222-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1222-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-14

Product code OAP

K183329Class IILaser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity / cleared 2019-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)