The Recall Desk

Manufacturer

Iradimed Corporation

3 recalls in our database name Iradimed Corporation as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2023-04-05

Of the 3 recalls from Iradimed Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-1310-2023·2023-04-05

    Iradimed MRidium MRI Infusion Pump Syringe Adapter Sets Recalled for Occlusion Risk

    Iradimed is recalling MRidium MRI 1000 Series Infusion Set Syringe Adapter Sets due to a defective part that can limit venting function and cause occlusion, potentially interrupting medication delivery.

    Product
    Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1874-2013·2013-08-14

    Iradimed MRidium Dose Reduction System Recall for Infusion Rate Errors

    Iradimed is recalling MRidium 1145 Dose Reduction System kits because they may display incorrect infusion rates, posing a risk of over- or under-infusion.

    Product
    MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR Infusion Pump System). The MRidium 3860+MRI Infusion pump are intended for general hospital or clinical use by medical professional whenever it is required to infuse patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0446-2013·2012-12-05

    Iradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect

    Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.

    Product
    The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only, d
    Category
    Medical Device
    Distribution
    Distributed nationwide