Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

ICU Medical medical devices: approvals, recalls and adverse events

Stock: ICUI. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

159

De Novo: 0

PMA approvals

17 supplements

Recalled products

1,311

119 class I

Adverse event reports

106K

426 deaths reported

How many recalls does ICU Medical have?

ICU Medical has 1,311 recalled medical device products in 254 recall actions in the records, 119 of them class I (the most serious kind). The newest recall started on Aug 20, 2026. In 2025 it had 79 recalled products.

How many medical devices has ICU Medical had cleared or approved?

159 510(k) clearances, 0 De Novo grants and 1 original PMA approvals for high-risk devices, plus 17 PMA supplements (changes to approved devices). The newest decision was on Sep 18, 2026.

How many adverse event reports name ICU Medical devices?

106,064 reports in total: 426 deaths, 9,829 injuries and 95,219 malfunctions were reported. 17,042 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	4	0	0	0
2025	5	0	0	0
2024	1	0	0	0
2023

Newest clearances and approvals

NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)
K262532 · 510(k) clearance · Sep 18, 2026
LifeShield Infusion Safety Software Suite
K252130 · 510(k) clearance · Apr 2, 2026
OTTO Disinfecting Cap
K252006 · 510(k) clearance · Mar 27, 2026
ClaveQS Bag
K251980 · 510(k) clearance · Mar 20, 2026
Clave Neutral-Displacement Needlefree Connectors
K250616 · 510(k) clearance · Jun 5, 2025
Plum Solo Precision IV Pump
K242114 · 510(k) clearance · Apr 2, 2025
Plum Duo Precision IV Pump
K242115 · 510(k) clearance · Apr 2, 2025
LifeShield Infusion Safety Software Suite
K242117 · 510(k) clearance · Apr 2, 2025
Rio Drug Reconstitution Transfer Device
K243985 · 510(k) clearance · Jan 22, 2025
Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe
K232943 · 510(k) clearance · May 31, 2024
Cogent Hemodynamic Monitoring System; Cogent HMS
K232048 · 510(k) clearance · Dec 20, 2023

Devices with the most adverse event reports

By product code, all years

Pump, Infusion (FRN, class 2)41,481
Set, Administration, Intravascular (FPA, class 2)20,819
Pump, Infusion, Pca (MEA, class 2)8,456
Tube Tracheostomy And Tube Cuff (JOH, class 2)5,931
Stopcock, I.V. Set (FMG, class 2)3,235
Tube, Tracheostomy (W/Wo Connector) (BTO, class 2)2,916
Warmer, Thermal, Infusion Fluid (LGZ, class 2)2,265
Tube, Tracheal (W/Wo Connector) (BTR, class 2)2,034
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ, class 2)1,919

All device makers and procedures · ICUI stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to ICUI with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	16	0	11,672	18
2025	79	20	17,042	20
2024	88	45	19,379	36
2023	32	6	6,450	28
2022	16	7	9,011	28
2021	49	3	4,853	20
2020	151	3	7,038	23
2019	46	9	8,249	14
2018	51	0	5,688	19
2017	99	13	3,036	39
2016	209	0	3,084	18
2015	14	0	1,350	15
2014	31	11	1,373	17
2013	87	1	1,201	7
2012	8	1	869	6

Newest recalls

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-760
Class II · Aug 20, 2026 · Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous
Class II · Jun 24, 2026 · ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent applica
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Class II · Jun 10, 2026 · In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Class II · Jun 10, 2026 · In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the
Oncology sets with drip chambers
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
Plum administration sets
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
Oncology sets with drip chambers
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
IV Sets with drip chambers
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
IV Sets with drip chambers
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride
IV Sets with drip chambers
Class II · May 12, 2026 · Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride