Facility

Cutler Campus

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

Key facts

2recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3032745446
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	330 Cutler Dr North Salt Lake, UT, US 84054
Registration status	Active · expires 2026
Parent company	BUNNELL INCORPORATED (owner-operator 1719232)
Brand names	Life Pulse High Frequency Ventilator; LifePulse High Frequency Ventilator

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Ventilator, High Frequency
Product code LSZ (opens in a new tab) · Class III · Unknown

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.

All facilities operated by BUNNELL INCORPORATED

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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