All

Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue

The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.

All

Class I Recall Expanded for Alaris Pump Infusion Sets

The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.

All

Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks

A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.

All

Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue

The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.

Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise

May 29, 2025

While total recalls and units affected declined in Q1 2025, the number of Class I events increased.

Baxter Issues Alert to Solution Sets Users for Assembly Issue

Jan 3, 2025

Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to an assembly issue that led to inverted slide clamps.

Philips Updates Users About Aerosol Risk for Ventilators

Nov 26, 2024

Philips has updated instructions for several ventilators to address aerosol deposits on internal sensors when used with in-line nebulizers.

Phasitron 5 Breathing Circuits Recalled for Nickel Coating Issue

Nov 7, 2024

Percussionaire is recalling Phasitron 5 breathing circuits due to a nickel coating issue that may aerosolize nickel and pose health risks. Customers are advised to dispose of or return affected products, with specific short-term use guidelines for necessary situations.