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Smiths Medical ASD, Inc.

Smiths Medical ASD, Inc. Recalls

All product recalls associated with Smiths Medical ASD, Inc..

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Recall Summary

Total Recalls

86

Past Year

9

Class I (Serious)

0

Most Recent

Apr 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 86 recalls

CADD-Solis HPCA Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis VIP Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD-Solis Infusion Pump (Smiths Medical) – Thermal Damage (2025)

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

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Apr 10, 2025

Nationwide

• Smiths Medical ASD, Inc.

CADD-Solis VIP Pump (Smiths Medical) – Occlusion Alarm (2025)

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CADD Solis Pump (Smiths Medical) – Wireless Connection (2025)

Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

FDAApr 10, 2025Nationwide• Smiths Medical ASD, Inc.

CAPNOCHECK Airway Adapter (Smiths Medical) – Breakage Risk (2025)

Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

FDAFeb 14, 2025Nationwide• Smiths Medical ASD, Inc.

Portex Endotracheal Tube (Smiths Medical) – Diameter Inconsistency (2025)

Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

ProPort Venous Access System (Smiths Medical) – Port Housing Separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

ProPort Plastic Venous System (Smiths Medical) – port housing separation (2025)

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

FDAFeb 13, 2025Nationwide• Smiths Medical ASD, Inc.

PORTEX Venn Tracheal Tube Introducer (Smiths Medical) – fluid ingress risk (2024)

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

FDAOct 28, 2024Nationwide• Smiths Medical ASD, Inc.

PORTEX Tracheal Tube Exchange Guide (Smiths Medical) – fluid ingress risk (2024)

Smiths Medical has identified a potential for ingress of fluid into the device during reprocessing. The ingress takes place at the rear of the device between the end cap and the tube. This could lead to staining of the device or allowing the fluid to remain in the device. In addition, the Hypochlorite Solution (200ppm) and the 4% Acetic Acid disinfectants recommended in the IFU may be inadequate according to the disinfection standards for this type of device.

FDAOct 28, 2024Nationwide• Smiths Medical ASD, Inc.

Medex NICU Monitoring Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar Kids Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex Arterial Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar Monitoring Set (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar 84in Single Set (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar DPT Stopcocks (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar Kids 10in Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar Single 60in Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.

Medex TranStar Kids 7in Kit (Smiths Medical) – Pressure Monitoring (2024)

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.

FDASep 24, 2024Nationwide• Smiths Medical ASD, Inc.