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ICU Medical, Inc.

ICU Medical, Inc. Recalls

All product recalls associated with ICU Medical, Inc..

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Recall Summary

Total Recalls

248

Past Year

47

Class I (Serious)

10

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 61–80 of 248 recalls

ICU Medical, Inc.: Product Description/Item: ChemoLock Bag Spike, 10 units/C...

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

FDAJun 27, 2022Nationwide• ICU Medical, Inc.

AMINOSYN II Amino Acid Injection (ICU Medical) – Particulate Matter (2021)

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

FDASep 3, 2021Nationwide• ICU Medical Inc

ICU Medical, Inc.: REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLo...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

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FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHO...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF K7040-001 Spinning Spiros Closed Male Luer - Product ...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin ...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 20120-01 Spiros" Closed Male Luer - Product Usage:...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF Spinning Spiros Closed Male Luer - Product Usage: pr...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Us...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/I...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Sp...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH3397 Oncology Kit w/Spiros, Red Cap, Bag Spike w/Cl...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/I...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SE...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Small...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set ...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Prod...

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

FDAMar 16, 2021Nationwide• ICU Medical, Inc.