Class IOngoingZ-1682-2025
Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Smiths Medical ASD, In…MNMay 14, 2025
Smiths Medical ASD, Inc. recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 20 recalls
Class IOngoingZ-1681-2025
Smiths Medical ASD, Inc. recalls CADD-Solis Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Smiths Medical ASD, In…MNMay 14, 2025
Class IOngoingZ-1668-2025
Smiths Medical ASD, Inc. recalls CADD-Solis VIP Ambulatory Infusion Pump
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.
Smiths Medical ASD, In…MNMay 14, 2025
Class IOngoingZ-1667-2025
Smiths Medical ASD, Inc. recalls CADD-Solis HPCA Ambulatory Infusion Pump
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.
Smiths Medical ASD, In…MNMay 14, 2025
Class IOngoingZ-1662-2025
Smiths Medical ASD, Inc. recalls CADD Solis HSPCA Pump ***Updated 5/27/26*** Scope updated to apply specifically to cus…
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.
Smiths Medical ASD, In…MNMay 14, 2025
Class IIOngoingZ-1405-2025
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter
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.…
Smiths Medical ASD, In…MNMar 26, 2025
Class IIOngoingZ-1404-2025
Smiths Medical ASD, Inc. recalls CAPNOCHECK BCI Airway Adapter
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.…
Smiths Medical ASD, In…MNMar 26, 2025
Class IOngoingZ-1288-2025
Smiths Medical ASD, Inc. recalls smiths medical ProPort Low Profile Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, In…MNMar 26, 2025
Class IOngoingZ-1287-2025
Smiths Medical ASD, Inc. recalls smiths medical ProPort Low Profile Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, In…MNMar 26, 2025
Class IOngoingZ-1286-2025
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, In…MNMar 26, 2025
Class IOngoingZ-1285-2025
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, In…MNMar 26, 2025
Class IOngoingZ-1284-2025
Smiths Medical ASD, Inc. recalls smiths medical ProPort Plastic Venous Access System
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Smiths Medical ASD, In…MNMar 26, 2025