The FDA has posted 20 enforcement recalls from Smiths Medical ASD, Inc. since 2025, including 18 Class I (most serious) recalls. Most recent report: May 14, 2025.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
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.
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.
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.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
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.…
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
Firm name as filed with the FDA: “Smiths Medical ASD, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.