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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 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Disposable Transducer 1/EA, Product Code REF MX950
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex Arterial Kit 1/EA, Product Code REF MX7827
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Single ICP Set 1/EA, Product Code REF MX20897
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD, Inc. recalls medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Hazard: Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/15
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b)
Hazard: Uncertainty in the seal integrity of the sterile packaging.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.
October 30, 2024Medical DevicesFDA
Smiths Medical ASD Inc. recalls CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
Hazard: Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.