ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubi
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 85" (216 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accesso
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with C
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Steril
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Ster
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red),
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing ac
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 137" (348 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 3 Gang 4-Way Stopcock, Luer Lock, 1 Ext, Sterile
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessor
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogen
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory wit
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 108" 20 Drop Blood Set w/200 Micron Filter, Remv 3-Way Stopcock w/MicroClave¿, Clave¿, Rotating Luer, 1 Ext, Sterile
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 119" Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Hazard: Lack of assurance of sterility: Bags have potential to leak.
June 27, 2018DrugsFDA
ICU Medical Inc recalls 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Hazard: Lack of assurance of sterility: Bags have potential to leak.
May 16, 2018Medical DevicesFDA
ICU Medical, Inc. recalls Hemodynamic monitoring system (HMS), comprised of a Patient Interface Module (Part Number 58401-000 and a User Interface
Hazard: When continuous cardiac output monitoring with a pulmonary artery catheter is placed in the Pause mode, the catheter thermal coil may continue while in pause mode.
April 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Ite
Hazard: The infusion sets were manufactured with an incorrect spin collar.
April 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066,
Hazard: The infusion sets were manufactured with an incorrect spin collar.
April 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 7" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B9900-629, Ster
Hazard: The infusion sets were manufactured with an incorrect spin collar.
April 18, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 7" Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262. The firm name on
Hazard: The infusion sets were manufactured with an incorrect spin collar.