OMTech Desktop Laser Engraver — Class II medical device recall Z-2129-2024
Ongoing recall by Rygel Advanced Machines d/b/a Omtech Laser, reported 2024-06-19, distributed nationwide. Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
| Recall number | Z-2129-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | FDA mandated |
| Recalling firm | Rygel Advanced Machines d/b/a Omtech Laser, Anaheim, CA, United States |
| Recall initiated | 2024-06-07 |
| Classified | 2024-06-13 |
| Reported by FDA | 2024-06-19 |
| Distributed | Nationwide (US) |
| Quantity | 641 |
| Reason classes | labeling |
| Model numbers | DF0812-40BG, USB-032B-U1 |
Product
OMTech Desktop Laser Engraver
Reason for recall
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
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-2129-2024. 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.