Lumenis recalls

Lumenis has 10 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 27 Aug 2025. 2 are still ongoing.

Total recalls10since 2013

Last 12 months0reported

Class I220% of total

Ongoing2latest 27 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 1 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 2 20%Class II 8 80%Class III 0 0%

Why lumenis is recalled

Product types

By year

2025220%
2021110%
2016220%
2015220%
2014110%
2013220%

Ongoing lumenis recalls

2 active

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Device	CLASS II	OtoLase Starter Kit recalled by Lumenis	Lumenis	Sterility	Nationwide
12 Mar 2025Device	CLASS II	Lumenis Pulse 120H 30 amp recalled	Lumenis	Lead & Heavy Metals	PA

All lumenis recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
27 Aug 2025Device	CLASS II	OtoLase Starter Kit recalled by Lumenis	Lumenis	Sterility	Nationwide
12 Mar 2025Device	CLASS II	Lumenis Pulse 120H 30 amp recalled	Lumenis	Lead & Heavy Metals	PA
10 Nov 2021Device	CLASS I	IPL Coupling Gel, I L (AX1009013) of (AX1009018) recalled by Lumenis	Lumenis	Other	Nationwide
2 Nov 2016Device	CLASS II	FemTouch delivery system includes the FemTouch Kit recalled by Lumenis	Lumenis	Lead & Heavy Metals
25 May 2016Device	CLASS II	M22 System recalled by Lumenis	Lumenis	Other	12 states
23 Sep 2015Device	CLASS II	VersaCut+ Tissue Morcellator GA-0007500 The Lumenis recalled	Lumenis	Other	Nationwide
6 May 2015Device	CLASS II	Light Sheer Desire Diode Laser System recalled by Lumenis	Lumenis	Device Malfunction	Nationwide
8 Oct 2014Device	CLASS II	Array LaserLink recalled by Lumenis	Lumenis	Other	Nationwide
18 Sep 2013Device	CLASS II	Vision One Laser System recalled by Lumenis	Lumenis	Other	IL, NJ, PA
20 Feb 2013Device	CLASS I	VersaCut Tissue Morcellator recalled by Lumenis	Lumenis	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.