Lumenis recalls
Lumenis appears in 10 official U.S. recall notices indexed by RecallRadar, most recently on 2025-08-27.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- OtoLase Starter Kit
FDA Device · Class II · 2025-08-27 · Lumenis - (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System
FDA Device · Class II · 2025-03-12 · Lumenis - IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063)
FDA Device · Class I · 2021-11-10 · Lumenis - FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecolo…
FDA Device · Class II · 2016-11-02 · Lumenis - Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971)
FDA Device · Class II · 2016-05-25 · Lumenis - Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct…
FDA Device · Class II · 2015-09-23 · Lumenis - Light Sheer Desire Diode Laser System with XC Handpiece Accessory options
FDA Device · Class II · 2015-05-06 · Lumenis - Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pat…
FDA Device · Class II · 2014-10-08 · Lumenis - Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053
FDA Device · Class II · 2013-09-18 · Lumenis - The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation an…
FDA Device · Class I · 2013-02-20 · Lumenis