The Recall Desk

Manufacturer

Lumenis, Inc.

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

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2021-11-10

Of the 3 recalls from Lumenis, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) 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

  • SevereFDA (Devices)·Z-0194-2022·2021-11-10

    IPL Coupling Gel and EcoGel 200 Recalled for Bacterial Contamination

    Lumenis, Inc. is recalling IPL Coupling Gel and EcoGel 200 due to potential bacterial contamination. Approximately 11,064 units were distributed worldwide.

    Product
    IPL Coupling Gel, I L (AX1009013), 12 pack of 0.25 L (AX1009018), 6 pack of 1 L (AX1009019 or AX1009063); and IPL Coupling Gel or EcoGel 200, 0.25 L (AX1009012) manufactured by Eco-Med Pharmaceutical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2014·2014-10-08

    Lumenis Array LaserLink Recall for Erroneous Retinal Pattern Display

    Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.

    Product
    Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2013·2013-09-18

    Lumenis Vision One Laser System Recalled for Unintended Laser Exposure

    Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.

    Product
    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
    Category
    Medical Device
    Distribution
    3 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.