RegWardenFDA facility compliance records
Company

Monteris Medical Corp

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2016: 1 recalls; 2017: 1 recalls1’14’151’161’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2017-10-05
    The firm received complaints that involved an unanticipated interaction between a NeuroBlate system and 1.5 Tesla (1.ST) MRI systems.
  • Class ITerminated2016-03-25
    Monteris received a report that the sapphire lens on a 2.2SF probe fractured during a LITT procedure, with resulting introduction of C02 into the patient's brain.
  • Class IITerminated2014-10-03
    Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe.

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. “Monteris Medical Corp — 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-10042500-monteris-medical-corp/

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