CLASS II ONGOING Device recall · Reported 22 Mar 2023 · FDA Enforcement Report

Recreo Hair Growth Laser Comb recalled by OMM Imports

OMM Imports is recalling Recreo Hair Growth Laser Comb, distributed nationwide in the US. The recall was initiated on 1 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesClass 3R Zero Gravity Recreo Hair Growth Laser Comb

Quantity recalled1620 units shipped to United States

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1222-2023
FDA event ID: 91839
Recalling firm: OMM Imports, Miami Beach, FL
Classification: Class II
Status: Ongoing
Recall initiated: 1 Sep 2022
FDA classified: 14 Mar 2023
Reported: 22 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

1 Sep 2022	Recall initiated by company
14 Mar 2023	Classified by FDA	+194 days
22 Mar 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Recreo Hair Growth Laser Comb

Where it was distributed

Worldwide and Nationwide including DC and Puerto Rico

Nationwide District of Columbia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

Class 3R Zero Gravity Recreo Hair Growth Laser Comb

Where was it sold?

Worldwide and Nationwide including DC and Puerto Rico

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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