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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 181–200 of 248 recalls

ICU Medical, Inc.: 9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 ...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Va...

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.

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FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, Na...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave,...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroCla...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoC...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (4...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, ...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, ...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave,...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-O...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, ...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off)...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off,...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: SURPLUG Nano Connector.1 unit per pouch, 100 multivac pou...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.

ICU Medical, Inc.: 29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Sto...

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.

FDAJul 6, 2020Nationwide• ICU Medical, Inc.