Facility

IRADIMED CORPORATION

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

Key facts

3recalls · 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)	3005053560
Establishment type	Manufacture Medical Device
Location	12705 Ingenuity Dr Orlando, FL, US 32826
Registration status	Active · expires 2026
Parent company	IRADIMED CORPORATION (owner-operator 9070201)
Brand names	Mridium 3860+ MRI Infusion Pump/ Monitoring System

Activity by year

Recalls (3)
Inspections (2)

Devices registered here (1)

Pump, Infusion
Product code FRN (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5725

Recalls & enforcement

Class IIOngoing2023-02-24
Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating to a defective injection molded part which can limit the effectiveness of the syringe venting function which then can result in occlusion.
Class ITerminated2013-07-01
The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. This can result in a risk of over-infusion or under-infusion if the infusion is started with this rate value.
Class IITerminated2012-08-24
Iradimed Corporation is recalling MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001 because a section of the device does not meet specifications.

FDA inspections (2)

VAI2019-06-17
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-07-18
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 IRADIMED CORPORATION

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. “IRADIMED CORPORATION (FEI 3005053560) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005053560-iradimed-corporation/

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