Infusion Pumps recalls

546 medical device recalls in the infusion pumps category are on file with the FDA, from 2012 to 9 Sep 2026.

Total recalls546since 2012

Last 12 months146reported

Class I11120% of total

Ongoing278latest 9 Sep 2026

Recalls per month, last 24 months

click a bar for that month

2Oct '24 2 0 2Jan '25 0 1 0Apr 4 4 2Jul 5 4 2Oct 1 117 15Jan '26 2 0 1Apr 0 3 2Jul 1 2

Severity split

Class I 111 20%Class II 431 79%Class III 4 1%

Why infusion pumps is recalled

Companies

By year

2026265%
202514226%
20245610%
2023265%
2022102%
2021224%
2020356%
2019458%
2018387%
2017132%

Ongoing infusion pumps recalls

278 active

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	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

All infusion pumps recalls, newest first

546 total

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS I	Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product recalled	Baxter Healthcare	Other	Nationwide
22 Jul 2026Device	CLASS II	Plum Solo Precision IV Pump, v1.0.3 recalled by ICU Medical	ICU Medical	Other	Nationwide
1 Jul 2026Device	CLASS II	Intera Oncology Intera 3000 Hepatic Artery Infusion Pump recalled	Boston Scientific	Packaging Defects	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
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Spectrum IQ Infusion Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	OH

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.