RegWardenFDA facility compliance records
Company

Lumenis Be Ltd.

3 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2021: 1 recalls1’131’14’15’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class ITerminated2021-10-14
    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-…
  • Class IITerminated2014-08-15
    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.
  • Class IITerminated2013-08-19
    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Lumenis Be Ltd. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10082799-lumenis-be-ltd/

Not open yet

Alerts for Lumenis Be Ltd.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.