Class IIOngoingZ-2554-2026
IPG Medical Corporation recalls Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
Software anomaly that causes a false display of error code 5018.
IPG Medical Corporatio…MAJul 1, 2026
Powered Laser Surgical Instrument recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 12 recalls
Class IIOngoingZ-1695-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus SOLTIVE Pro SuperPulsed Laser System Product Name: SOLTIVE Pro Las…
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.…
Olympus Corporation of…PAApr 8, 2026
Class IIOngoingZ-1694-2026
Olympus Corporation Of The Americas recalls Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Pre…
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.…
Olympus Corporation of…PAApr 8, 2026
Class IIOngoingZ-1558-2026
Lutronic Corporation recalls CLARITY II Laser System
Reports of devices sparking/popping and potentially burning patients.
Lutronic CorporationMar 18, 2026
Class IICompletedZ-1130-2026
LEASEIR TECHNOLOGIES SLU recalls Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b…
The console label for affected devices is missing the "DANGER" symbol.
LEASEIR TECHNOLOGIES S…Jan 28, 2026
Class IIOngoingZ-2344-2025
LUMENIS, LTD. recalls OtoLase Starter Kit
The potential for unsterilized product within finished product labeled as sterile.
LUMENIS, LTD.Aug 27, 2025
Class IIOngoingZ-1923-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fib…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1922-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1921-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulse…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1920-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed La…
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use.…
Olympus Corporation of…PAJun 18, 2025
Class IIOngoingZ-1715-2025
Olympus Corporation Of The Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed La…
Preset treatment parameters are not consistently being used in accordance with the IFU.
Olympus Corporation of…PAMay 7, 2025
Class IIOngoingZ-1290-2025
LUMENIS, LTD. recalls (1) Lumenis Pulse 120H 30 amp
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…
LUMENIS, LTD.Mar 12, 2025