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Recall company profile

ICU Medical, Inc. Recalls

Overview of recall records associated with ICU Medical, Inc., including dates, categories and classifications where available.

360recall records

Sep 23, 2026latest record date

Apr 18, 2018earliest record date

Recall history in this database

Classification mix: Class II: 340, Class I: 20.

Medical DeviceOct 28, 2020

ICU Medical 128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang recall — FDA Z-0244-2021

Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-2001-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-1996-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-2002-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-1998-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-1997-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-1999-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 20, 2020

ICU Medical Central Venous Catheters are indicated for the assessment of hemodynamic status recall — FDA Z-2000-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical The Cogent Hemodynamic Monitoring System recall — FDA Z-1927-2020

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

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way recall — FDA Z-1917-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 recall — FDA Z-1916-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing recall — FDA Z-1913-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 recall — FDA Z-1918-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For recall — FDA Z-1911-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger recall — FDA Z-1912-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave recall — FDA Z-1915-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks recall — FDA Z-1919-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way recall — FDA Z-1920-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 13, 2020

ICU Medical REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port recall — FDA Z-1914-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceMay 6, 2020

ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI recall — FDA Z-1835-2020

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…

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceOct 30, 2019

ICU Medical Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # recall — FDA Z-0171-2020

A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show…

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets recall — FDA Z-0127-2020

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

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0134-2020

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

Class IIFDA: TerminatedICU Medical Inc.

Medical DeviceOct 23, 2019

ICU Medical Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets recall — FDA Z-0130-2020

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

Class IIFDA: TerminatedICU Medical Inc.

Understanding this recall history

This page summarizes recall records in which the official source identifies ICU Medical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.