# FDA recall Z-1310-2023

> **Iradimed Corporation** · Class II · device recall initiated 2023-02-24.

## Product

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set - Syringe Adapter Set, REF 1057-50,

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-1310-2023
- **Recalling firm:** Iradimed Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-24
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winter Springs, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2023

## Citation

> AI Analytics. FDA recall Z-1310-2023. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1310-2023. Source: US FDA. Licensed CC0.

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