Iradimed Corporation MRidium MRI 1000 Series Infusion Sets… recallZ-1310-2023 · Iradimed Corporation · initiated Feb 24, 2023
Class II Open, Classified All recalls posted in March 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Iradimed Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Iradimed Corporation issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/24/2023 by certified mail. The notice explained the issue and the risk and provided updated instructions for use to mitigate the potential risk of inlet occlusion. For further information concerning this issue or have any questions, please contact Iradimed support via email at [email protected] or via telephone at 407-677-8022.
Recall details
- Recall number
- Z-1310-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 24, 2023
- Posted by the FDA
- Mar 30, 2023
- Recalling firm
- Iradimed Corporation
- Quantity
- 3285 boxes of 50 devices
- Product code
- FRN
- FDA submissions
- K050301, K143369, K090087
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Canada, Chile, Denmark, Germany, Great Britain, Hong Kong, Indonesia, Italy, Korea, Kuwait, Malaysia, Netherlands, Nicaragua, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Romania, Serbia, Singapore, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates.
Product description
Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,
Code information (models, lots, serial numbers)
UDI di 10856038001048, Lot Numbers: 21K50N, exp. 11/30/2023; 22A03N, exp. 01/31/2024; 22A59N, exp. 2/29/2024; 22B54N, exp. 2/29/2024; 22D15N, exp. 4/30/2024; 22D28N, exp. 4/30/2024; 22D58N, exp. 4/30/2024; 22I17N, exp. 9/30/2024; 031851, exp. 9/30/2024; 22J46N, exp. 10/31/2024; 032198, exp. 11/30/2024; 22L02N,exp. 12/31/2024; 032822, exp. 1/31/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Iradimed 1057Iradimed Corp. · Pump, Infusion1 recall7 reports
Other devices under the same FDA submission
2 devices cleared under K050301, K143369, K090087 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Iradimed 3860+Iradimed Corp. · Pump, Infusion1 death13 reports
- Iradimed 1056Iradimed Corp. · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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