RegWardenFDA facility compliance records
Facility

Cutler Campus

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2017: 1 inspections; 2022: 1 recalls; 2024: 1 inspections1’12’13’14’15’161’17’18’19’20’211’22’231’24’25’26
  • Recalls (2)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2022-11-02
    Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect normal ventilator performance, which may lead to hypercarbia, hypoxia, and gas trapping.
  • Class ITerminated2012-11-19
    Customer complaints received indicate the heater wire insulation can melt, causing a short which creates sparking and smoke, in the circuit close to the humidifier cartridge. Bunnell is recalling all lots of circuits distributed between March 12, 2012 and November 30, 2012.

FDA inspections (2)

  • VAI2024-04-19
    Voluntary Action Indicated · Compliance: Devices
  • NAI2017-08-08
    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. “Cutler Campus (FEI 3032745446) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3032745446-cutler-campus/

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