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Smiths Medical ASD Recalls
293 recalls on record · July 18, 2012 to May 14, 2025 · 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.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a)
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
October 20, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181
Hazard: Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
September 15, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Hazard: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
September 15, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
Hazard: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.
September 8, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.
Hazard: The incorrect device is contained in the package.
July 7, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controll
Hazard: One lot number of a specific model of ULTRAperc Percutaneous Dilation Tracheostomy Kit, 9.0mm may have been incorrectly labeled as a 7.0mm ID kit.
June 16, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G
Hazard: Specific models and lot numbers of the Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29Gx1/2 odd number line graduation markings on the syringe barrel were skewed approximately 20 degrees upward.
May 5, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls ACE MDI Spacer with Small Mask - Product Usage: designed to assist with the delivery of aerosolized medications from met
Hazard: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
May 5, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial
Hazard: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transduce
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascul
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Numbe
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the directio
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATO
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures.
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to contr
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling.
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
April 28, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Hazard: Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
March 3, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 39
Hazard: Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.
January 27, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory P
Hazard: Shipping box may contain wrong model.
January 6, 2021Medical DevicesFDA
Smiths Medical ASD Inc. recalls PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Hazard: A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.