RegWardenFDA facility compliance records
Facility

EVENT MEDICAL, LTD.

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

Activity by year

FDA actions on record by year2015: 1 recalls; 2019: 1 inspections; 2022: 1 inspections120152016201720181201920202021120222023202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Ventilator, Continuous, Facility Use
    Product code CBK (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5895

Recalls & enforcement

  • Class ITerminated2015-10-13
    A component on the systems power board can fail in a manner which can cause the ventilator to shut down without alarming.

FDA inspections (2)

  • VAI2022-05-18
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2019-08-01
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “EVENT MEDICAL, LTD. (FEI 3006135941) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006135941-event-medical-ltd/

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