Infusion Pumps recalls

549 medical device recalls in the infusion pumps category are on file with the FDA, from 2012 to 23 Sep 2026.

Total recalls549since 2012

Last 12 months149reported

Class I11220% of total

Ongoing281latest 23 Sep 2026

Recalls per month, last 24 months

click a bar for that month

2Nov '24 0 2 0Feb 1 0 4May 4 2 5Aug 4 2 1Nov 117 15 2Feb 0 1 0May 3 2 1Aug 5 0

Severity split

Class I 112 20%Class II 433 79%Class III 4 1%

Why infusion pumps is recalled

Companies

By year

2026295%
202514226%
20245610%
2023265%
2022102%
2021224%
2020356%
2019458%
2018387%
2017132%

Ongoing infusion pumps recalls

281 active

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
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 recalled	Baxter Healthcare	Other	Nationwide

All infusion pumps recalls, newest first

549 total

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS I	BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl	BD Switzerland Sarl	Other	Nationwide
23 Sep 2026Device	CLASS II	IV Non-Dedicated Gravity Administration Sets with drip chambers recalled	ICU Medical	Foreign Material	Nationwide
23 Sep 2026Device	CLASS II	Plum administration sets recalled by ICU Medical	ICU Medical	Particulate Matter	Nationwide
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 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	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Infusion Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
17 Jun 2026Device	CLASS II	Plum Duo Precision IV Pump recalled by ICU Medical	ICU Medical	Device Malfunction	Nationwide
1 Apr 2026Device	CLASS II	Tandem pumps are battery-operated infusion pumps capable recalled	Tandem Diabetes Care	Device Malfunction	CA
25 Feb 2026Device	CLASS II	Spectrum IQ Infusion Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	OH
4 Feb 2026Device	CLASS II	BD Alaris" Pump Module recalled by CareFusion 303	CareFusion 303	Device Malfunction	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	Sigma Spectrum Infusion Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	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	Plum Duo Infusion Pump, List Numbers: 400020401 (US) recalled	ICU Medical	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Packaging Defects	Nationwide
21 Jan 2026Device	CLASS II	Medline Kits containing B. Braun IV Administration Sets recalled	Medline Industries	Other	Nationwide
10 Dec 2025Device	CLASS I	Ivenix Infusion System, Lvp Primary Administration Set recalled	Fresenius Kabi USA	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.