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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 221–240 of 248 recalls

5% Dextrose 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

Sodium Chloride Injection (ICU Medical) – Potential Leakage (2018)

Lack of assurance of sterility: Bags have potential to leak.

Class IIModerate

FDAMay 31, 2018Nationwide• ICU Medical Inc

Dextrose Injection (ICU Medical) – Potential Leakage (2018)

Lack of assurance of sterility: Bags have potential to leak.

Class IIModerate

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Page 12 of 13Next

FDA

May 31, 2018

Nationwide

• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Potential Leakage (2018)

Lack of assurance of sterility: Bags have potential to leak.

Class IIModerate

FDAMay 31, 2018Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Potential Leakage (2018)

Lack of assurance of sterility: Bags have potential to leak.

Class IIModerate

FDAMay 31, 2018Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Potential Leakage (2018)

Lack of assurance of sterility: Bags have potential to leak.

Class IIModerate

FDAMay 31, 2018Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Particulate Matter (2017)

Presence of Particulate Matter; stainless steel

Class IIModerate

FDAJul 26, 2017Nationwide• ICU Medical Inc

ICU Medical, Inc.: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Dro...

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Class IHigh

FDAAug 19, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clav...

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Class IHigh

FDAAug 19, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit...

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Class IHigh

FDAAug 19, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Dro...

ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

Class IHigh

FDAAug 19, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Cap Change Kit with MicroClave Clear Connector, Item No. ...

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: CAP Change Kit w/MicroClave Clear, Item No. B78109 BD ...

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: Port Access Kit with MicroClave Clear Connector, Item No....

ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

Class IIModerate

FDAAug 5, 2014Nationwide• ICU Medical, Inc.