PlainRecalls

Iradimed Corporation

Compiled from official public sources by the publisher.

3 recalls on record · Latest: Apr 5, 2023

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Agency notice ledger

Federal filing book Iradimed Corporation LIGHT-BOOK · SINGLE-AGENCY

#3,705 of 14,151 · 3 notices · 0.003% archive

  • BOOK 3 notices
  • RANK #3,705 of 14,151
  • SHARE 0.003% archive
  • AGENCY FDA Devices (3)
  • CAT medical devices
  • CATS 1 category
  • LATEST Apr 5, 2023
  • PHOTO 3B Medical, Inc.

Nearest notice-volume peer: 3B Medical, Inc. (0 notice gap)

Iradimed Corporation accounts for about 0.003% of the 104,423-notice archive on 3 distinct filings — a light share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Iradimed Corporation sits among 14,151 recalling firms

Iradimed Corporation ranks 3,705th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Iradimed Corporation vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

3 3705th of 14151 higher than 9,908 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Iradimed Corporation in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Iradimed Corporation holds about 0.003% of archive notices alongside 3 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Apr 5, 2023

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
FDA Devices Critical Aug 14, 2013

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 patients with intra-venous or intra-arterial fluids before, during or after magnetic Resonance imagining (MRI) scans.
FDA Devices Moderate Dec 5, 2012

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, do not resterilize, and is available only by prescription. Device made in U.S.A. by Iradimed Corporation located in Winter Park, FL 32792. Lot LBG001, Exp 07/2016 The MRidium MRI Infusion Pumps and Infusion Sets are

Iradimed Corporation is a small archive contributor

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (3 here).

3B Medical, Inc. 3 7-Eleven, Inc. 3 A & C Best Food Trading 3 A B Nutrition, Inc. 3 A L I Technologies Ltd 3

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

3B Medical, Inc. 3 A L I Technologies Ltd 3 Abeon Medical Corporation 3 Acist Medical Systems 3

Frequently Asked Questions

How many federal recall notices name Iradimed Corporation? ▼
PlainRecalls indexes 3 distinct federal recall events naming Iradimed Corporation, aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Iradimed Corporation sit among other recalling firms? ▼
Iradimed Corporation ranks #3,705 of 14,151 by distinct recall-event count among 14,151 firms in this archive (70th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Iradimed Corporation's notices? ▼
FDA Devices accounts for 3 of this firm's 3 indexed notices.
What product category dominates Iradimed Corporation's filing book? ▼
Filings for Iradimed Corporation span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Iradimed Corporation: 3 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Iradimed Corporation; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026