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Recall Observatory FDA recall evidence

Device product

Recreo Hair Growth Laser Comb

Z-1222-2023

September 01, 2022

Class II

Product summary

Firm
OMM Imports, Inc. dba Zero Gravity
Event
Event 91839
Status
Ongoing
Classification
Class II
Quantity
1620 units shipped to United States
Official record key
device-enforcement:Z-1222-2023

Official wording

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.

Code information: Class 3R Zero Gravity Recreo Hair Growth Laser Comb

Distribution pattern: Worldwide and Nationwide including DC and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.