Class II

Medical Device Recall: OMTech Desktop Laser Engraver

Rygel Advanced Machines d/b/a Omtech Laser · June 7, 2024

Reason for Recall

Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.

Distribution

US Nationwide

States Affected

NATIONWIDE

Quantity Affected

641

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2129-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Rygel Advanced Machines d/b/a Omtech Laser Medical Device Recall: OMTech Desktop Laser Engraver | SafeCheck