OMTech Desktop Laser Engraver (Rygel Advanced Machines) – Interlocks Missing (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OMTech Desktop Laser Engraver
Brand
Rygel Advanced Machines d/b/a Omtech Laser
Lot Codes / Batch Numbers
Model: DF0812-40BG, USB-032B-U1
Products Sold
Model: DF0812-40BG, USB-032B-U1
Rygel Advanced Machines d/b/a Omtech Laser is recalling OMTech Desktop Laser Engraver due to Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
Recommended Action
Per FDA guidance
OMTech Laser intends to send a Important Safety Warning letter to each customer of the Product. The letter includes the following information: a. A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard. b. Instructions with respect to the use of the product pending the correction of the defect. c. A clear evaluation in nontechnical terms of the hazards reasonably related to the failure to comply. The letter also states OMTech Laser, at its own expense, will provide all necessary materials to repair the Product, including detailed service installation instructions, to each customer of the Product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026