ICU Medical recalls

ICU Medical has 654 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 29 Jul 2026. 123 are still ongoing. 54 were reported in the last 12 months. The most frequent reason is packaging defects.

Total recalls654since 2012

Last 12 months54reported

Class I264% of total

Ongoing123latest 29 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 1 0Jan '25 0 2 0Apr 1 2 1Jul 1 6 1Oct 38 2 7Jan '26 0 0 0Apr 1 3 2Jul 0 0

Severity split

Class I 26 4%Class II 628 96%Class III 0 0%

Why icu medical is recalled

Product types

Brands

Sodium Chloride20%
Potassium Chloride20%

By year

2026132%
2025548%
202430%
202351%
202291%
2021335%
202013320%
2019406%
20186911%
2017162%

Ongoing icu medical recalls

123 active

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
27 May 2026Device	CLASS II	Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled	ICU Medical	Packaging Defects	Nationwide

All icu medical recalls, newest first

654 total

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Device	CLASS II	Hotline Fluid Warming Set, single use device recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
17 Jun 2026Device	CLASS II	Plum Solo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Lead & Heavy Metals	Nationwide
27 May 2026Device	CLASS II	Oncology Kit w/60" Appx, Smallbore Ext Set w/ChemoLock Port recalled	ICU Medical	Packaging Defects	Nationwide
28 Jan 2026Device	CLASS II	Plum Duo Precision IV Pump, List Numbers: 400020403 (US) recalled	ICU Medical	Other	Nationwide
28 Jan 2026Device	CLASS II	Plum Solo Precision IV Pump, List Numbers: 400010401 (US) recalled	ICU Medical	Other	Nationwide
28 Jan 2026Device	CLASS II	Tego Connector recalled by ICU Medical	ICU Medical	Packaging Defects	Nationwide
28 Jan 2026Device	CLASS II	Plum Duo Infusion Pump, List Numbers: 400020401 (US) recalled	ICU Medical	Other	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.