LUMENIS Recalls
10 recalls on record · February 20, 2013 to August 27, 2025 · Medical Devices
Recalls by year
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21
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 27, 2025Medical DevicesFDA
LUMENIS, LTD. recalls OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incis
Hazard: The potential for unsterilized product within finished product labeled as sterile.
March 12, 2025Medical DevicesFDA
LUMENIS, LTD. recalls (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, La
Hazard: 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 to not power on.
November 10, 2021Medical DevicesFDA
Lumenis, Inc. recalls IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupli
Hazard: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health.
November 2, 2016Medical DevicesFDA
Lumenis Limited recalls FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional
Hazard: The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
May 25, 2016Medical DevicesFDA
Lumenis Ltd recalls Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
Hazard: Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.
September 23, 2015Medical DevicesFDA
Lumenis recalls Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intende
Hazard: There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
May 6, 2015Medical DevicesFDA
Lumenis Limited recalls Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
Hazard: Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.
October 8, 2014Medical DevicesFDA
Lumenis, Inc. recalls Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the t
Hazard: Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.
September 18, 2013Medical DevicesFDA
Lumenis, Inc. recalls Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular
Hazard: Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.
February 20, 2013Medical DevicesFDA
Lumenis Limited recalls The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualizatio
Hazard: Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.