Smiths Medical Recalls Infusion Pumps Over Safety Concerns

Smiths Medical is recalling certain CADD-Solis Ambulatory Infusion Pumps to update instructions addressing three critical issues that could risk patient safety. While no injuries or deaths have been reported, the FDA classified the recall as Class I, its most serious level.

The issues include:

• False alarms that halt or delay infusions,

• Thermal damage from faulty battery components that could overheat,

• Network failures disrupting communication with wireless modules.

To mitigate risks, Smiths advised users on clearing alarms, checking for battery damage, and ensuring hospital networks are compatible before system updates.

The recall follows a string of regulatory actions since ICU Medical acquired Smiths in 2021. ICU Medical’s CEO said the company has proactively reviewed thousands of complaints and software anomalies to guide safety actions.

10-06-2025