Data Foundry

Medical device recalls 2023

Iradimed Corporation MRidium MRI 1000 Series Infusion Sets — Class II medical device recall Z-1310-2023

Ongoing recall by Iradimed Corporation, reported 2023-04-05, distributed nationwide. Certain Iradimed 1057 Syringe Adapter Sets, used with the MRidium MRI infusion pump, have a problem relating t

Recall numberZ-1310-2023
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmIradimed Corporation, Winter Springs, FL, United States
Recall initiated2023-02-24
Classified2023-03-30
Reported by FDA2023-04-05
DistributedNationwide (US)
Countries outside the USAE, AT, CA, CH, CL, DE, DK, ES, GB, HK, ID, IT, KR, KW, MY, NI, NL, OM, PE, PH, PK, PL, PT, QA, RO, RS, SG, TH, TW, ZA
Reason classesdevice malfunction
UPC / GTIN / UDI-DI10856038001048
Lot numbers031851, 032198, 032822, 21K50N, 22A03N, 22A59N, 22B54N, 22D15N, 22D28N, 22D58N, 22I17N, 22J46N, 22L02N
Model numbers1057-50
Expiration dates2023-11-30, 2024-01-31, 2024-02-29, 2024-04-30, 2024-09-30, 2024-10-31, 2024-11-30, 2024-12-31, 2025-01-31

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1310-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.