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
August 27, 2014FDACAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packag…Z-2293-2014
August 27, 2014FDAPort Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes…Z-2295-2014
August 27, 2014FDACap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes …Z-2294-2014
August 13, 2014FDASingle Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe …Z-2164-2014
August 13, 2014FDASingle Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item…Z-2161-2014
August 13, 2014FDATranspac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, I…Z-2165-2014
August 13, 2014FDATrifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrod…Z-2158-2014
August 13, 2014FDAArterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Pati…Z-2159-2014
August 13, 2014FDATrifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Nee…Z-2160-2014
August 13, 2014FDATranspac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2…Z-2157-2014
August 13, 2014FDATranspac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 …Z-2163-2014
August 13, 2014FDAArterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, It…Z-2162-2014
January 15, 2014FDA184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron P…Z-0662-2014
January 15, 2014FDA5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2…Z-0702-2014
January 15, 2014FDA6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Lu…Z-0660-2014
January 15, 2014FDA28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector,…Z-0704-2014
January 15, 2014FDA14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, …Z-0677-2014
January 15, 2014FDA7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connect…Z-0668-2014
January 15, 2014FDA120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopco…Z-0699-2014
January 15, 2014FDA10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp,…Z-0693-2014
January 15, 2014FDA13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, …Z-0676-2014
January 15, 2014FDA7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotat…Z-0667-2014
January 15, 2014FDA6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, …Z-0681-2014
January 15, 2014FDA10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000,…Z-0674-2014
January 15, 2014FDA31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, …Z-0663-2014

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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