Z-2129-2024Class II

OMTech Desktop Laser Engraver

Name: Z-2129-2024 OMTech Desktop Laser Engraver
Creator: Rygel Advanced Machines d/b/a Omtech Laser
Published: 2024-06-07
License: https://open.fda.gov/license/

Rygel Advanced Machines d/b/a Omtech Laser / initiated 2024-06-07 / Open, Classified / root cause: labeling and UDI

FDA source

Rygel Advanced Machines d/b/a Omtech Laser began a recall of OMTech Desktop Laser Engraver on 2024-06-07. FDA classified it as Class II and gives the reason as "Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2129-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-07
Posted: 2024-06-14
Recalling firm: Rygel Advanced Machines d/b/a Omtech Laser
Product: OMTech Desktop Laser Engraver
Product code: RIM Laser Marker, Cutter, Or Engraver, Tabletop, Consumer
Reason for recall: Lack of redundant interlocks, missing required labels and certification labels as required by 21 1010.2.
Root cause tag: labeling and UDI
FDA root cause: Radiation Control for Health and Safety Act
Action: 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.
Quantity in commerce: 641
Distribution: US Nationwide
Product codes and lots: Model: DF0812-40BG, USB-032B-U1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2129-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2129-2024	Class II	Ongoing	FDA Mandated	2024-06-19	2024-06-13

Product code RIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)