Manufacturer
7 recalls in our database name Theralase Inc. as the manufacturing or recalling firm.
Of the 7 recalls from Theralase Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 660 nm laser diodes may be below rated power output.
Theralase Inc. is recalling 92 TLC-2000 Therapeutic Medical Laser Systems because the 905 nm laser diodes may be below rated power output.
Theralase Inc. is recalling 202 TLC-2000 Therapeutic Medical Laser System Power Packs because the internal battery pack was not tested to IEC-60601-1-2 standards.
Theralase Inc. is recalling 76 TLC-2000 laser systems because they were shipped with an incorrect power supply model.
Theralase Inc. is recalling 18 TLC-2000 Therapeutic Medical Laser Systems because the laser probes emit electromagnetic interference exceeding safety standards.
Theralase Inc. is recalling 306 TLC-2002 Power Packs for the TLC-2000 Therapeutic Medical Laser System because they were shipped without a Unique Device Identification (UDI) label and incorrectly labeled as CE Marked.
Theralase Inc. is recalling 41 TLC-2000 Therapeutic Medical Laser Systems because they were shipped without required Unique Device Identification (UDI) labels.