Smiths Medical ASD Inc.
130 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Smiths Medical ASD Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-10-30FDA-DeviceClass IImedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9544
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9543
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Disposable Transducer 1/EA, Product Code REF MX950
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.
- 2024-10-30FDA-DeviceClass IImedex Arterial Kit 1/EA, Product Code REF MX7827
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
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.
- 2024-10-30FDA-DeviceClass IImedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
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.
- 2024-10-30FDA-DeviceClass IImedex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Single ICP Set 1/EA, Product Code REF MX20897
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.
- 2024-10-30FDA-DeviceClass IImedex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
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.
- 2024-10-30FDA-DeviceClass IIsmiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
Uncertainty in the seal integrity of the sterile packaging.
- 2024-10-30FDA-DeviceClass IIsmiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
Uncertainty in the seal integrity of the sterile packaging.
- 2024-10-30FDA-DeviceClass IIsmiths medical portex, Y' PIECE 15MM, REF 100/276/000
Uncertainty in the seal integrity of the sterile packaging.
- 2024-10-30FDA-DeviceClass IIsmiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS
Uncertainty in the seal integrity of the sterile packaging.
- 2024-10-30FDA-DeviceClass IIsmiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060; b) AIRWAY NASOPHARYNGEAL 6.0MM, REF 100/210/060JP; c) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070; d) AIRWAY NASOPHARYNGEAL 7.0MM, REF 100/210/070JP; e) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080; f) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JP; g) AIRWAY NASOPHARYNGEAL 8.0MM, REF 100/210/080JS; h) AIRWAY NASOPHARYNGEAL 9.0MM, REF 100/210/090; i) AIRWAY NASOPHA
Uncertainty in the seal integrity of the sterile packaging.
- 2024-10-30FDA-DeviceClass IIENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28
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.
- 2024-10-30FDA-DeviceClass IIENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28
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.
- 2024-10-30FDA-DeviceClass IICADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP
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.
- 2024-10-30FDA-DeviceClass IICADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
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.
- 2024-10-30FDA-DeviceClass IICADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24
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.
- 2024-10-30FDA-DeviceClass IICADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24
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.
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