Recreo Hair Growth Laser Comb — Class II medical device recall Z-1222-2023
Ongoing recall by OMM Imports, Inc. dba Zero Gravity, reported 2023-03-22, distributed nationwide. The firm distributed the laser products without affixing the warning, aperture, certification, and identificat
| Recall number | Z-1222-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OMM Imports, Inc. dba Zero Gravity, Miami Beach, FL, United States |
| Recall initiated | 2022-09-01 |
| Classified | 2023-03-14 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Quantity | 1,620 units |
| Reason classes | labeling |
Product
Recreo Hair Growth Laser Comb
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1222-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.