Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Recreo Hair Growth Laser Comb

FDA Recall Z-1222-2023 · Posted 2023-03-14

Recalling FirmOMM Imports, Inc. dba Zero Gravity
Recall StatusOpen, Classified
Product CodeOAP
Date Initiated2022-09-01
Product Quantity1620 units shipped to United States

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.

Firm 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.

Root Cause

Error in labeling

Distribution Pattern

Worldwide and Nationwide including DC and Puerto Rico

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183329Laser Hair TherapyOmm Imports, Inc. D/B/A Zero Gravity · 2019-01-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑