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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

Class I (Serious)

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 201–220 of 248 recalls

ICU Medical, Inc.: REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse E...

Incorrect filter assemblies in IV administration set.

FDAJul 1, 2020Nationwide• ICU Medical, Inc.

Lactated Ringer's Injection (ICU Medical) – Particulate Matter (2020)

Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

Class IHigh

FDAMay 8, 2020Nationwide• ICU Medical Inc

ICU Medical, Inc.: The Cogent Hemodynamic Monitoring System. REF58400-000, G...

Firm identified software issues which leads to the patient ID and patient information not being stored in the system.

FDA

1...9 101112 13

Page 11 of 13Next

Feb 14, 2020

Nationwide

• ICU Medical, Inc.

ICU Medical, Inc.: Central Venous Catheters are indicated for the assessment...

Inability for the guidewire to pass through the needles included with the catheter kits.

FDAJan 2, 2020AL, CA, FL +16 more• ICU Medical, Inc.

Lactated Ringer's Injection (ICU Medical) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IHigh

FDAOct 25, 2019Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IHigh

FDAOct 25, 2019Nationwide• ICU Medical Inc

ICU Medical, Inc.: REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin ...

There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

FDAOct 4, 2019AL, AK, AZ +41 more• ICU Medical, Inc.

ICU Medical Inc: Infusion Pump I.V. Administration, specifically Plum Micr...

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

FDAJul 29, 2019Nationwide• ICU Medical Inc

ICU Medical, Inc.: ICU Medical Cogent Hemodynamic Monitoring System, Cogent ...

Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.

FDAJul 12, 2019Nationwide• ICU Medical, Inc.

Sodium Chloride Injection (ICU Medical) – CGMP Deviation (2019)

CGMP Deviations

Class IIModerate

FDAFeb 4, 2019Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Sterility and Leak Risk (2018)

Lack of Assurance of Sterility; bags have the potential to leak

Class IIModerate

FDAOct 8, 2018Nationwide• ICU Medical Inc

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ICU Medical, Inc. Recalls

Recall Summary

ICU Medical, Inc.: REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse E...

Lactated Ringer's Injection (ICU Medical) – Particulate Matter (2020)

ICU Medical, Inc.: The Cogent Hemodynamic Monitoring System. REF58400-000, G...

ICU Medical, Inc.: Central Venous Catheters are indicated for the assessment...

Lactated Ringer's Injection (ICU Medical) – Particulate Matter (2019)

Sodium Chloride Injection (ICU Medical) – Particulate Matter (2019)

ICU Medical, Inc.: REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin ...

ICU Medical, Inc.: REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, ...

ICU Medical, Inc.: REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Ga...

ICU Medical, Inc.: REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv...

ICU Medical, Inc.: REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin ...

ICU Medical, Inc.: REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave",...

ICU Medical, Inc.: REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primar...

ICU Medical, Inc.: REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W...

ICU Medical, Inc.: REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotatin...

ICU Medical, Inc.: REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroCl...

ICU Medical Inc: Infusion Pump I.V. Administration, specifically Plum Micr...

ICU Medical, Inc.: ICU Medical Cogent Hemodynamic Monitoring System, Cogent ...

Sodium Chloride Injection (ICU Medical) – CGMP Deviation (2019)

Sodium Chloride Injection (ICU Medical) – Sterility and Leak Risk (2018)