The FDA has posted 12 enforcement recalls of powered laser surgical instrument devices since 2025, none of them Class I (most serious). Most recent report: Jul 1, 2026.
Software anomaly that causes a false display of error code 5018.
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable.…
Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable.…
Reports of devices sparking/popping and potentially burning patients.
The console label for affected devices is missing the "DANGER" symbol.
The potential for unsterilized product within finished product labeled as sterile.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Preset treatment parameters are not consistently being used in accordance with the IFU.
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Powered Laser Surgical Instrument”). Informational only — verify against the FDA before acting.