Discus Dental Recalls SL3 Soft-Tissue Laser Due to Fiber Breakage
Discus Dental LLC is recalling 150 SL3 Soft-Tissue Lasers because the fiber optic system contains a fragile glass filament that broke near the handpiece.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a mechanical defect (broken filament) but does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Discus Dental LLC is recalling 150 units of the SL3 Soft-Tissue Laser (Model LR2002). The recall is being initiated because the laser is equipped with a fiber optic Unifiber system that contains a fragile glass filament, which broke near the handpiece.
The affected units were distributed nationwide, including in Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Missouri, Montana, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, Virginia, and Washington.
The source text does not specify instructions for consumers or healthcare providers regarding the next steps for this recall.
The recalled product
- Product
- SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
- Manufacturer
- Discus Dental LLC
- Hazard
- Affected units
- 150
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 (1)
- Model LR2002
Distribution
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