Iradimed recalls

Iradimed has 3 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 5 Apr 2023. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls3since 2012

Last 12 months0reported

Class I133% of total

Ongoing1latest 5 Apr 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 33%Class II 2 67%Class III 0 0%

Why iradimed is recalled

Product types

Infusion Pumps3100%

By year

2023133%
2013133%
2012133%

Ongoing iradimed recalls

1 active

Reported	Class	Recall	Company	Reason	Where
5 Apr 2023Device	CLASS II	MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set recalled	Iradimed	Device Malfunction	Nationwide

All iradimed recalls, newest first

3 total

Reported	Class	Recall	Company	Reason	Where
5 Apr 2023Device	CLASS II	MRidium MRI 1000 Series Infusion Sets, MRI Infusuui Set recalled	Iradimed	Device Malfunction	Nationwide
14 Aug 2013Device	CLASS I	MRidium 1145 Dose Reduction System (DERS) drug library kit recalled	Iradimed	Other	Nationwide
5 Dec 2012Device	CLASS II	The name is MRidium Series 1000 MR Infusion Sets recalled by Iradimed	Iradimed	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.