The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1222-2023·Announced 2023-03-22

Hair Growth Laser Comb Recalled for Missing Safety Warnings and Labels

OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a laser medical device lacking required safety labels and warnings, posing theoretical risk of harm. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products without reported injury warrant a High severity score.

Plain-English summary

OMM Imports, Inc., doing business as Zero Gravity, is recalling 1,620 units of the Recreo Hair Growth Laser Comb that were distributed nationwide and internationally, including to Puerto Rico and the District of Columbia.

The recalled units were distributed without affixing required warning labels, aperture labels, certification labels, and identification labels. The firm also failed to provide safety information, label reproductions, label locations, and warning statements in the user manual. These missing labels and documentation create a safety hazard, as users would not have adequate warnings about proper use and potential risks from the Class 3R laser device.

Consumers who have purchased this product should stop using it until they have reviewed the missing safety information. Contact OMM Imports, Inc. for guidance on obtaining the required safety documentation or returning the product.

The recalled product

Product
Recreo Hair Growth Laser Comb
Manufacturer
OMM Imports, Inc. dba Zero Gravity
Category
Medical Device — Laser Device
Hazard
Affected units
1,620

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Class 3R Zero Gravity Recreo Hair Growth Laser Comb

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same hazard · missing warnings

See all →

Similar recalls