Z-1186-2013Class II

SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232...

Name: Z-1186-2013 SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232...
Creator: Discus Dental LLC
Published: 2011-07-21
License: https://open.fda.gov/license/

Discus Dental LLC / initiated 2011-07-21 / Terminated / root cause: design

FDA source

Discus Dental LLC began a recall of 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... on 2011-07-21. FDA classified it as Class II and gives the reason as "The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1186-2013
Classification: Class II
Status: Terminated
Initiated: 2011-07-21
Posted: 2013-04-29
Terminated: 2013-04-29
Recalling firm: Discus Dental LLC
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
Product code: GEX Powered Laser Surgical Instrument
Reason for recall: The firm is initiating this recall of the SL3 Soft Tissue Laser equipped with a fiber optic Unifiber system which contains a fragile glass filament because the fiber broke near the hand piece.
Root cause tag: design
FDA root cause: Device Design
Action: DISCUS Dental, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 21, 2011. The letter described the product, problem and action to be taken. Customers were instructed tocontact Discus Dental at 1-888-427-9279 for a no-cost replacement. For questions regarding this recall call 310-845-8200.
Quantity in commerce: 150 units
Distribution: Nationwide Distribution including AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT NH, NJ, NM, NV, NY, OH, PA, SD, TX, UT, VA, and WA.
Product codes and lots: Model LR2002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1186-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1186-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-29

Product code GEX

K102639Class IISl3Discus Dental, LLC / cleared 2010-12-01

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)