The Recall Desk

Manufacturer

Lumenis Ltd

3 recalls in our database name Lumenis Ltd as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2025-08-27

Of the 3 recalls from Lumenis Ltd we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-2344-2025·2025-08-27

    OtoLase starter kits recalled over potentially unsterilized product labeled as sterile

    OtoLase Starter Kits, UPN AC-2003748, batches 32644549 and 32769567, are recalled because finished product labeled as sterile may not have been sterilized. 13 units are affected.

    Product
    OtoLase Starter Kit; UPN: AC-2003748. Indicated for a variety of surgical uses including ablation, coagulation, incision, excision, and vaporization of soft tissue.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1290-2025·2025-03-12

    Lumenis Pulse 120H Laser System Charger May Prevent Device Startup

    Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.

    Product
    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1669-2016·2016-05-25

    Lumenis M22 IPL Acne Filters Recalled for Superficial Burn Risk

    Lumenis Ltd is recalling M22 IPL Acne Filters due to a risk of superficial burns when using the device.

    Product
    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).
    Category
    Medical Device
    Distribution
    12 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Lumenis

company that develops and manufactures minimally-invasive clinical solutions for the Surgical, Ophthalmology & Aesthetic markets

Country
Israel
Founded
1991

Official website

Source: Wikidata (Q4043248), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.