OMTech Desktop Laser Engraver recalled for missing safety interlocks
Rygel Advanced Machines recalls OMTech Desktop Laser Engravers due to missing safety interlocks and labeling. The devices lack required redundant interlocks and certification labels that prevent accidental laser exposure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for missing critical safety interlocks on a laser device that pose risk of serious eye injury or burn injury. No illnesses or injuries have been reported, but the defect creates a concrete hazard where injury has not yet been reported.
Plain-English summary
Rygel Advanced Machines d/b/a Omtech Laser has recalled the OMTech Desktop Laser Engraver (Models DF0812-40BG and USB-032B-U1) due to safety defects. The recalled units lack redundant safety interlocks and are missing required certification labels as mandated by FDA regulations (21 CFR 1010.2).
Safety interlocks on laser devices prevent accidental exposure to laser radiation during operation or when the device is open. Without these critical safety features, users are at risk of serious eye injury or burns from unintended laser exposure.
Approximately 641 units have been distributed nationwide. Consumers who own affected models should stop using the device immediately and contact Rygel Advanced Machines for information on a replacement or repair. The FDA has classified this recall as Class II, indicating a serious safety concern that could result in significant injury.
The recalled product
- Product
- OMTech Desktop Laser Engraver
- Manufacturer
- Rygel Advanced Machines d/b/a Omtech Laser
- Affected units
- 641
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model: DF0812-40BG
- USB-032B-U1
Distribution
Distributed nationwide across the United States.
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