RegWardenFDA facility compliance records
Company

IRADIMED CORPORATION

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2023: 1 recalls1’121’13’14’15’16’17’18’19’20’21’221’23’24’25’26
  • Recalls (3)

Registered facilities (1)

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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “IRADIMED CORPORATION — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9070201-iradimed-corporation/

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