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
May 20, 2020FDACentral Venous Catheters are indicated for the assessment of hemodynamic status through r…Z-2001-2020
May 13, 2020FDAREF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infus…Z-1916-2020
May 13, 2020FDAREF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotatin…Z-1917-2020
May 13, 2020FDAThe Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-00…Z-1927-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline …Z-0127-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inl…Z-0131-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inl…Z-0143-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inl…Z-0134-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline …Z-0145-2020
October 23, 2019FDAInfusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inl…Z-0130-2020
April 24, 2019FDAicumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-…Z-1097-2019
November 14, 2018FDA0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 040…D-0216-2019
November 14, 2018FDA5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-0…D-0215-2019
August 15, 2018FDA88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Lu…Z-2641-2018
August 15, 2018FDA112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating…Z-2640-2018
August 15, 2018FDA140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave…Z-2621-2018
August 15, 2018FDA115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Con…Z-2650-2018
August 15, 2018FDA143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In …Z-2648-2018
August 15, 2018FDA120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock,…Z-2658-2018
August 15, 2018FDA132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-W…Z-2646-2018
August 15, 2018FDA116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rota…Z-2657-2018
August 15, 2018FDA99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, St…Z-2626-2018
August 15, 2018FDALopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a s…Z-2613-2018
June 27, 2018FDA0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 6…D-0882-2018
June 27, 2018FDA0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 6…D-0884-2018

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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