ICU Medical, Inc.: 242 recalls on record

Recalls filed with 1 agency: FDA (242).

First recall on record: August 8, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 15 · Class II: 227

Most recent recalls

DateAgencyProduct
January 15, 2014FDA7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connec…Z-0684-2014
January 15, 2014FDA13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Ye…Z-0696-2014
January 15, 2014FDA7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. …Z-0694-2014
January 15, 2014FDA6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer…Z-0666-2014
January 15, 2014FDA78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamp…Z-0687-2014
January 15, 2014FDA8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 …Z-0679-2014
January 15, 2014FDA17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part …Z-0665-2014
January 15, 2014FDA8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoC…Z-0669-2014
January 15, 2014FDA11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, P…Z-0695-2014
January 15, 2014FDA7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A100…Z-0688-2014
January 15, 2014FDA7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No…Z-0691-2014
January 15, 2014FDA183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syp…Z-0661-2014
October 17, 2012FDA3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, …Z-0055-2013
August 8, 2012FDACardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets …Z-2129-2012
August 8, 2012FDA94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, N…Z-2130-2012
August 8, 2012FDAFlush Kit w 3 Way Off Stopcock Product Usage: Flush KitZ-2131-2012
August 8, 2012FDAHigh Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.Z-2128-2012

Questions about this company

How many recalls does ICU Medical, Inc. have?
Recalert has 242 U.S. recalls on record for ICU Medical, Inc., published between August 8, 2012 and September 23, 2026.
Which agencies have handled ICU Medical, Inc. recalls?
ICU Medical, Inc. appears as the recalling firm in recalls from: FDA (242).

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