RegWardenFDA facility compliance records
Facility

VYCOR MEDICAL INC

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2017: 1 inspections1’12’13’14’15’161’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Retractor, Self-Retaining, For Neurosurgery
    Product code GZT (opens in a new tab) · Class II · Neurology · 21 CFR 882.4800

Recalls & enforcement

  • Class ITerminated2012-08-21
    Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.

FDA inspections (1)

  • VAI2017-07-19
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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. “VYCOR MEDICAL INC (FEI 3005880844) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005880844-vycor-medical-inc/

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