Facility

INFINIUM MEDICAL, INC.

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

Key facts

1recalls · worst Class II

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)	3007513035
Establishment type	Manufacture Medical Device
Location	12151 62ND ST., N, Largo, FL, US 33773
Registration status	Active · expires 2026
Parent company	INFINIUM MEDICAL, INC. (owner-operator 10028895)
Brand names	Omni Express; Omni VS

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Product code MWI (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2300

Recalls & enforcement

Class IIOngoing2019-05-31
The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option.

FDA inspections (2)

VAI2023-11-08
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-05-15
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.

All facilities operated by INFINIUM MEDICAL, INC.

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. “INFINIUM MEDICAL, INC. (FEI 3007513035) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007513035-infinium-medical-inc/

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